Light delivery system with a fiber optic disposable for preventing, reducing and/or eliminating infections during institutional or in-home use

ABSTRACT

An electromagnetic radiation (EMR) delivery system for delivering EMR at wavelengths, intensities, exposures, and durations to locations inside and/or outside a patient’s body in, on, and surrounding a tubular structure such as a tube, catheter, and/or a catheter extension to prevent, reduce, and/or eliminate infectious agents in, on, or surrounding the tubular structure. A smart light engine box generates the therapeutic EMR, controls treatments, and monitors the health of the system. A fiber optic disposable makes at-home use of the EMR delivery system possible. Specific embodiments of the EMR delivery system for use with peritoneal dialysis catheters, dialysis accesses, and hemodialysis accesses are also disclosed.

RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.17/579,657, filed Jan. 20, 2022 and titled ELECTROMAGNETIC RADIATIONDELIVERY AND MONITORING SYSTEM AND METHODS FOR PREVENTING, REDUCINGAND/OR ELIMINATING CATHETER-RELATED INFECTIONS DURING INSTITUTIONAL ORIN-HOME USE, which is a continuation-in-part of U.S. Pat. ApplicationNo. 16/364,051, filed Mar. 25, 2019 and titled METHODS AND APPARATUS TODELIVER THERAPEUTIC, NON-ULTRAVIOLET VERSATILELY VIA A CATHETER RESIDINGIN A BODY CAVITY (hereinafter the “Parent Application”), which is acontinuation-in-part of U.S. Pat. Application No. 15/668,266, filed Aug.3, 2017 and titled METHODS AND APPARATUS TO DELIVER THERAPEUTIC,NON-ULTRAVIOLET ELECTROMAGNETIC RADIATION TO INACTIVATE INFECTIOUSAGENTS AND/OR TO ENHANCE HEALTHY CELL GROWTH VIA A CATHETER RESIDING INA BODY CAVITY (hereinafter the “Grandparent Application”) now issued asU.S. Pat. No. 10,307,612, on Jun. 4, 2019, which is acontinuation-in-part of U.S. Pat. Application No. 13/801,750, filed Mar.13, 2013 and titled METHODS AND APPARATUS TO INACTIVATE INFECTIOUSAGENTS ON A CATHETER RESIDING IN A BODY CAVITY (hereinafter the“Great-Grandparent Application”), now issued as U.S. Pat. No. 9,808,647on Nov. 7, 2017, which claimed the benefit of U.S. ProvisionalApplication No. 61/686,432 filed Apr. 5, 2012 and was entitled HINSLASER LIGHT CATHETER. This application also is a continuation-in-part ofU.S. Pat. Application No. 17/000,736, filed Aug. 24, 2020, and titledMETHODS AND APPARATUS TO DELIVER THERAPEUTIC, NON-ULTRAVIOLETELECTROMAGNETIC RADIATION IN A DIALYSIS SYSTEM (hereinafter the “SecondParent Application”), which is a continuation-in-part of the ParentApplication, U.S. Pat. Application No. 16/364,051, filed Mar. 25, 2019and titled METHODS AND APPARATUS FOR REMOVABLE CATHETER VISUAL LIGHTTHERAPEUTIC SYSTEM ELECTROMAGNETIC RADIATION VERSATILELY VIA A CATHETERRESIDING IN A BODY CAVITY. Additionally, this application also is acontinuation-in-part of U.S. Pat. Application No. 16/747,315, filed Jan.20, 2020 and titled METHOD AND APPARATUS FOR REMOVABLE CATHETER VISUALLIGHT THERAPEUTIC SYSTEM (hereinafter the “Third Parent Application”),which is continuation-in-part of U.S. Pat. Application No. 15/424,732,filed Feb. 3, 2017 and titled METHOD AND APPARATUS FOR REMOVABLECATHETER VISUAL LIGHT THERAPEUTIC SYSTEM, now issued as U.S. Pat. No.10,543,338 on Jan. 28, 2020, which claimed the benefit of U.S.Provisional Application No. 62/292,028 filed Feb. 5, 2016, and entitledMETHOD AND APPARATUS FOR REMOVABLE CATHETER VISUAL LIGHT STERILIZATIONSYSTEM. Each of the related applications referred to in this paragraphis hereby incorporated by this reference as if fully set forth herein.

TECHNICAL FIELD

The present invention is a method and apparatus to provide versatiledelivery and monitoring of therapeutic doses of non-ultraviolet light toinactivate infectious agents residing on, within, or generally around acatheter while the catheter is residing within a body cavity or residingon, within, or around extension catheters and connectors outside thebody along the flow path of fluids such as dialysate and wastedialysate, blood, urine, medicating fluids, and the like, and tostimulate healthy cell growth within the body and at the entry/exit sitecausing a healing effect.

Such versatile delivery of therapeutic doses of non-ultraviolet lightmay employ controlled relative intensity and/or treatment regionspecific application of the therapeutic doses. This disclosure is of amedical device assembly, and particularly a light-energy source anddelivery components (sometimes including a disposable fiber opticintroducer), that utilizes non-ultraviolet visual therapeuticelectromagnetic radiation (EMR) at a high enough intensity to stimulatehealthy cell growth causing a healing effect and/or to reduce oreliminate infectious agents in, on, and around a catheter while thecatheter resides inside a body cavity and/or in, on, and around theextension catheters and connectors outside the body along the flow pathof fluids such as dialysate and waste dialysate.

Various exemplary embodiments of the present invention are describedbelow. Use of the term “exemplary” means illustrative or by way ofexample only, and any reference herein to “the invention” is notintended to restrict or limit the invention to exact features or stepsof any one or more of the exemplary embodiments disclosed in the presentspecification. References to “exemplary embodiment,” “one embodiment,”“an embodiment,” “some embodiments,” “various embodiments,” and thelike, may indicate that the embodiment(s) of the invention so describedmay include a particular feature, structure, or characteristic, but notevery embodiment necessarily includes a particular feature, structure,or characteristic. Further, repeated use of the phrase “in oneembodiment,” or “in an exemplary embodiment,” do not necessarily referto the same embodiment, although they may.

BACKGROUND

Catheters are tubular structures commonly used as channels to injectmedications into or retrieve fluid samples from a patient. Each cathetercomprises a tube, usually derived from plastic or other polymers, suchas silicone, polyurethane, and the like, that at least a portion thereofmay be inserted into an area of the body and may contain one or moreseparate lines in which these fluids may be delivered or retrieved. A“lumen” designates a pathway in the catheter that goes from outside thebody to inside the body. Catheters and other tubular structures are usedin various applications, including intravascularly, abdominally,urologically, gastrointestinally, ophthalmically, within the respiratorytract, within cranial space, within the spinal column, during dialysisand the like. In all cases, the catheter extends from outside the bodyto be placed inside of a space in the body where the catheter or aportion of a catheter assembly resides, herein referred to as a “bodycavity”. These devices frequently give rise to infections caused bygrowth of infectious agents in, on, and around the catheter and ontissue surrounding the catheter. Infectious agents can include bacteria,fungi, viruses, or the like that enter the body and lead to illness of apatient. Depending on the location of the catheter placement, theseinfections can arise in the form of urinary tract infections, bloodstream infections, soft tissue infection, and the like.

Catheter related infections (CRIs) are a large problem in medicine,leading to high morbidity and mortality rates. Current methods ofreducing or eliminating the number of infectious agents in, on, around acatheter are of low efficacy. Typically, catheters will be removed ifthey are suspected to be harboring infectious agents, increasing boththe cost associated with treatment and patient discomfort. Variousmethods to deter or eliminate growth of infectious agents in, on, andaround catheters have been attempted, such as using sterile handlingtechniques, antibiotics, and replacing the catheter when an infection issuspected. Despite these techniques, infections resulting from cathetersremain a major problem. According to the Centers for Disease Control andPrevention, over 31,000 people died specifically from catheter-relatedbloodstream infections in 2010. These infections, along with urinarytract infections, gastrointestinal infections, dialysis-relatedinfections and other infections from catheters, increase medical costs,insurance costs, and patient discomfort.

Catheters come in various sizes. Those that are smaller in diameter,such as many PICC lines (peripherally inserted central catheters), havesmall diameter lumens. Such smaller diameter catheters may be suitablefor prolonged insertion. Consequently, with smaller diameter catheters,there may be inadequate thickness to the catheter wall to carry asterilization and/or healthy growth enhancing delivery system.

The use of ultraviolet (UV) light, disinfecting chemicals, cathetersimpregnated with drugs, to name a few, have been attempted to reduce theprevalence of infection. Many patents have attempted to utilize UV lightto disinfect catheters. Unfortunately, UV light is well known to causedamage to living cells. Methods to disinfect connectors, stopcocks, andvalves using the projection of sterilizing electromagnetic radiation(EMR) have also been attempted using 405 nm light to sterilize thesepoints, but these methods neglect disinfection of the catheter body aswell as the tip of the catheter.

The emergence of infectious agents that are resistant to currenttreatments, such as methicillin-resistance staphylococcus aureus (MRSA),further substantiate the need for another treatment of CRIs. To reducethe costs associated with removing and replacing the catheters from andinto the patient, there is a need for sterilization of the entirecatheter or catheter assembly while at least a portion of the catheterresides in the patient. Additionally, it would be advantageous to beable to stimulate healthy cell growth by providing therapeutic EMR viasuch indwelling catheters.

Immediate disinfection after placement could help prevent growth ofundesirable biofilm on the catheter. Biofilm comprises extracellularpolymeric material created by microorganisms after they adhere to asurface. This biofilm facilitates the growth of infectious agents and isvery difficult to break down once it has begun to grow.

The growth of infectious agents can result from agents outside thepatient (contamination during handling, at the point of access as thecatheter penetrates or crosses the skin, from the catheter hub, or fromany other exterior contamination) or from inside the patient, whereininfectious agents already in the body attach to the surface of thecatheter and proliferate. Scientific literature suggests thatapproximately 65% of CRI’s come from infectious agents residing on theskin of the patient (S. Öncü, Central Venous Catheter - RelatedInfections: An Overview with Special Emphasis on Diagnosis, Preventionand Management. The Internet Journal of Anesthesiology. 2003 Volume 7Number 1). These agents travel down the outside of the catheter andcolonize the catheter tip. For short term catheterization, this isbelieved to be the most likely mechanism of infection (Crump.Intravascular Catheter-Associated Infections. Eur J Clin Microbiol Dis(2000) 19:1-8). Thirty percent (30%) of CRIs are believed to come from acontaminated hub, in which infectious agents travel down the interior ofthe catheter (Öncü). This is believed to be the most likely mechanism ofinfection for long-term catheterization (Crump).

EMR in the range of 380-900 nm has been shown to be effective in killinginfectious agents. Research done by a group at the University ofStrathclyde shows that light in this range is effective in killingsurface bacteria in burn wards without harming the patients(Environmental decontamination of a hospital isolation room usingprojected high-intensity light. J Hosp Infect. 2010 Nov;76(3):247-51).Published Pat. Application 2010/0246169, written by the members whoconducted the study, utilizes ambient lighting to disinfect a largesurrounding area. The mechanism proposed by the team suggests that lightin this range leads to photosensitization of endogenous porphyrinswithin the bacteria, which causes the creation of singlet oxygen,leading to the death of the bacteria. (Inactivation of BacterialPathogens following Exposure to Light from a 405-NanometerLight-Emitting Diode Array. Appl Environ Microbiol. 2009Apr;75(7):1932-7).

Heretofore, however, there has never been apparatus or methods formaking or using such apparatus to disinfect a catheter safely andeffectively while it is still implanted in a patient. Accordingly, thereexists a need for methods and apparatus designed to delivernon-antibiotic, bactericidal therapeutics in-vivo. Such methods andapparatus, using novel technology, may provide removable delivery ofsafe, effective, and reproducible disinfection and/or enhance healthycell growth.

SUMMARY OF THE INVENTION

The exemplary embodiments of this disclosure relate to medical deviceassemblies for insertion into a cavity of a patient’s body and fordelivery from outside the body to inside the body and retrieval offluids from inside the body to outside the body. Each assembly comprisesan electromagnetic radiation (EMR) source for providing non-ultraviolet,therapeutic EMR having intensity sufficient to inactivate one or moreinfectious agents and/or to enhance healthy cell growth. Each assemblyeither comprises a catheter, a catheter extension, or may be used with acatheter having an elongate catheter body with at least one internallumen, a coupling end, and a distal end. This distal end is insertableinto the cavity of the patient’s body whether the cavity is venous,arterial, gastrointestinal, abdominal, urological, respiratory, cranial,spinal, or the like, wherein the indwelling catheter body may direct thefluid and/or the propagation of the therapeutic EMR axially relative tothe catheter body for radial delivery into a catheter extension or thecatheter, into the patient’s body and/or at the distal end. Also, whenappropriate, the therapeutic EMR may be directed at or into catheterextensions and connectors outside the body at or into the insertionarea. An optical element disposed within a lumen of the catheter bodyand/or within the catheter body acts conducive to the axial propagationof the therapeutic EMR relative to the catheter body. The opticalelement or another optical element also may be disposed to act conduciveto propagation of therapeutic EMR through at least one coupling elementto connect the EMR component to the insertable catheter component.

For the purposes of this disclosure the use of the term “therapeutic”should be understood to mean; of or relating to the treatment ofdisease, including reducing or eliminating infectious agents, as well asserving or performed to maintain health, including enhancing healthycell growth.

For the purpose of this disclosure the use of the phrase “controlledrelative intensity” should be understood to be a term of versatilitymeaning that the delivery of EMR at various desired intensities may becontrolled in any of a number of ways such as 1) by using differentsingle fibers; 2) by using different radial-emission locations and/orgradients; 3) by using multiple differing fibers; and 4) byretro-fitting the fiber type and/or design for tailored use with anexisting catheter or catheter extensions. The versatility contemplatedby the phrase “controlled relative intensity” is the ability to deliverEMR of the desired/appropriate intensities to desired location(s) attime(s) most effective within the broad range of types and sizes ofcatheters.

For the purpose of this disclosure the use of the phrase “treatmentregion specific” should be understood likewise to be a term ofversatility meaning that the delivery of EMR at various desiredintensities for desired dosing may be delivered to specific treatmentregions by utilizing fiber(s) with radial-emission capability compatiblewith the specific region or regions within the patient’s body and/or in,on, or around the catheter or catheter extensions and connectors to betreated by the application of EMR.

The exemplary medical device assembly comprises an EMR source, an EMRconduction system, and at least one coupling to connect the EMR sourceto the EMR conduction system. The EMR source provides non-ultraviolet,therapeutic EMR having intensity sufficient to inactivate one or moreinfectious agents and/or to stimulate healthy cell growth causing ahealing effect. In at least one exemplary embodiment, the EMR conductionsystem may be at least partially insertable into and removable from thelumen of an indwelling catheter or a catheter extension. Because the EMRconduction system is removably insertable, in yet another exemplaryembodiment, a differing, second EMR conduction system (or at least theoptical element of a second EMR conduction system) may also be removablyinsertable such that the two differing EMR conduction systems may beinterchangeably insertable into the same lumen of the catheter or intothe extended lumen of the catheter and into catheter extension(s).

In some exemplary embodiments, methods and apparatuses are provided foreffectively sterilizing a catheter and the area surrounding the catheterwhile the catheter is disposed in a body cavity. Such medical deviceassemblies use sterilizing EMR to reduce or eliminate the count ofinfectious agents in, on, or around the catheter and/or on or in tissuesurrounding the catheter while in a body cavity. In other exemplaryembodiments, systems (such as dialysis systems) may have catheterextensions (e.g., fluid extension lines) and connectors disposed outsidethe body for which effective sterilizing thereof enhances theprevention, reduction, and elimination of infectious agents throughoutthe system, including in, on, or around the catheter, in, on, or aroundcatheter extensions or connectors, and/or on or in tissue surroundingthe catheter while in a body cavity.

The EMR source can be from a single, multiple, or group of EMR sourcesincluding, but not limited to, a light emitting diode, a semiconductorlaser, a diode laser, an incandescent (filtered or unfiltered) and afluorescent (filtered or unfiltered) light source. This EMR source (ormultiple sources) provides non-ultraviolet, therapeutic EMR providingone or more wavelengths in the range of above 380 nm to about 904 nm. Toprovide sufficient inactivation of infectious species and/or stimulationof healthy cell growth, each EMR wavelength should be of a narrowspectrum and centered around one wavelength from the group. Theintensity should be sufficient to inactivate one or more infectiousagents and/or to stimulate healthy cell growth causing a healing effect.This group includes several wavelengths centered about: 400 nm, 405 nm,415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm, 475 nm, 632 nm, 632.8nm, 640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and904 nm.

The EMR source may require drivers and electronic support for fullfunctionality. Consideration should be given to accommodating thesupport hardware and/or software, which may encompass a significantportion of the EMR source’s functionality and efficacy. It is possiblethat the EMR source may generate heat, which could be detrimental to theEMR source and may need to be limited or dampened.

This disclosure describes a catheter (or a catheter assembly) having anelongate catheter body with at least one internal lumen, a coupling endand a distal end, the distal end being insertable into the cavity of thepatient’s body. The catheter body is meant to direct both the fluid andthe therapeutic EMR axially relative to the catheter body for deliveryinto the patient’s body at the insertion site, along the elongatecatheter body, and/or at the distal end. This disclosure includes anoptical element disposed within the catheter body and conducive to theaxial propagation of the therapeutic EMR through the catheter body.Finally, this disclosure describes at least one coupling element toconnect the radiation source to the catheter body. Further, the cathetermay be connected to one or more extension catheters (e.g., fluidextension lines) and connectors through which fluid is supplied orretrieved. It may be advantageous to have such extension catheters andconnectors also be conducive to the axial propagation of the therapeuticEMR therethrough so that the delivery of therapeutic EMR may enhance theprevention, reduction, and elimination of infectious agents within theoverall system.

The sterilizing EMR is transmitted down a specialized path within thecatheter via an optical element conducive to the axial propagation ofthe light. Various methods could be used to facilitate axial propagationof the light relative to the catheter, including a reflective coatingwithin a line of the catheter, a fiber optic cable, a lens, a waveguide,or the like. The light source can be a light-emitting diode (LED),laser, fiber optic filament, or the like.

One exemplary embodiment of the EMR source and support components issimplified to contain only the EMR source and necessary components. Inanother exemplary embodiment of the EMR conduction system, a passiveheat sink is required to diffuse the heat generated into the surroundingenvironment. In yet another exemplary embodiment of the EMR source, aheat sink may be coupled to at least one fan to actively dissipate heatgenerated by the EMR source. In other embodiments, multiple EMR sourcesconnected to separate individual optical elements or a single EMR sourcecapable of connecting to separate individual optical elements andproviding EMR of distinctly different intensities and/or wavelengths toseparate optical elements may be employed.

Of particular interest to this disclosure is the use of light between380 nm and about 900 nm wavelengths. Additionally, the intensity andpower of the light emitted bear significantly on the inactivation ofinfectious agents, thus a range of radiant exposures covering 0.1 J/cm²to 5 kJ/cm² (or in some instances up to 10 kJ/cm²), and a range ofpowers from 0.005 mW to 5 W (or in some instances up to 10 W), and powerdensity range covering 1 mW/cm² and 2 W/cm² (or in some instances up to5 W/cm²), are of interest for these exemplary device assemblies andmethods. These ranges of wavelengths, power densities, and radiantexposures have been shown to have either antimicrobial effects orpositive biological effects on healing tissue. These positive biologicaleffects include reduction of inflammatory cells, increased proliferationof fibroblasts, stimulation of collagen synthesis, angiogenesisinducement and granulation tissue formation.

For each exemplary embodiment described herein, the EMR conductionsystem and method for disinfection/healing could be utilized in manuallyor CPU controlled adjustable or predetermined duty cycle. If treatmentsbegin immediately after sterile procedure was initiated, device relatedinfections may be inhibited or prevented. This includes device-relatedbiofilm growth.

A treatment may include at least one wavelength of therapeutic EMR thatacts as a predominant wavelength selected to sterilize one or moretarget organisms and selected from the group of wavelengths centeredabout 400 nm, 405 nm, 415 nm, 430 nm, 440 nm, 445 nm, 455 nm, 470 nm,475 nm, 660 nm, and 808 nm, or a predominant wavelength selected topromote healing and healthy cell growth may be selected from the groupof wavelengths centered about 632 nm, 632.8 nm, 640 nm, 650 nm, 660 nm,670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904 nm. Another treatmentmay include alternating the predominant wavelength between a firstpredominant wavelength and a second predominant wavelength (differingfrom the first predominant wavelength) in a selected treatment pattern.Further, sterilizing EMR and EMR that stimulates healthy cell growth maybe transmitted alternatingly, simultaneously, in tandem. oralternatively.

A method for constructing an exemplary medical device assembly forinsertion into a cavity of a patient’s body and for delivery of a fluid(such as a dialysate, a saline solution, or hemodialysis freshenedblood) to or retrieval of a fluid (such as waste dialysate orunfreshened blood) from the patient’s body may comprise the steps of:locating an indwelling catheter or providing a catheter having anelongate catheter body with one or more internal lumens, a coupling endand an distal end, the distal end being previously inserted/insertableinto the cavity of the patient’s body; applying one or more opticalelements within one or more lumens of the catheter body (or an extensioncatheter) and/or within a wall of the catheter body, the optical elementbeing conducive to the axial propagation of therapeutic EMR relative tothe catheter body; and coupling at least one EMR source to the EMRconduction system and/or the catheter body (or an extension catheter),the EMR source for providing non-ultraviolet, therapeutic EMR having anintensity sufficient to inactivate one or more infectious agent and/orto enhance healthy cell growth.

In one exemplary embodiment, the device uses a catheter that is insertedinto a cavity of a patient’s body, wherein said catheter allows bothfluid and therapeutic EMR to travel axially relative to the catheterbody. The catheter also contains at least one coupling lumen to connectan EMR source that will transmit the therapeutic EMR through thecoupling lumen and axially relative to the catheter line. A couplingelement in this context will usually refer to a typical hub on thetherapeutic EMR source.

In at least one exemplary embodiment, a removably insertable EMRconduction system (i.e., an EMR conduction system that may be partiallyor fully inserted into a lumen of a catheter and may also be partiallyor fully extracted from disposition within a lumen of a catheter) maycomprise at least one optical element having an elongate body conduciveto the axial propagation of the therapeutic EMR through the elongatebody. This elongate body may have an exterior surface between a couplingend and a distal end. The exterior surface may have at least one radialemission portion wherein the radial emission facilitates the radialemission of therapeutic EMR from the elongate body proximate each radialemission portion. Again, because the removably insertable EMR conductionsystem may be fully extracted from within a lumen of the catheter, inanother exemplary embodiment, a differing, second removably insertableEMR conduction system (or at least the optical element of a second EMRconduction system) may be interchangeably insertable into the same lumenof the catheter. The second removably insertable EMR conduction systemmay differ in that it may have at least one radial emission portion thatdiffers from at least one radial emission portion of the interchangeableEMR conduction system.

At least one coupling connects the radiation source to the EMRconduction system and, in some exemplary embodiments, may comprise atleast one feature that allows for the coupling to be readily removablefrom the EMR conduction system. The exemplary coupling may be achievedby utilizing a uniquely designed connection, a pre-manufactured couplingsystem, or any combination thereof that optimizes the couplingefficiency and utility. Further, such couplings couple the removablyinsertable EMR conduction system to the EMR source and may comprise morethan one coupling with an intermediate section optimized to further thepropagation of the EMR. In one exemplary embodiment, the EMR source maybe coupled to a patch cable or EMR conduction extending segment, whichis then coupled to the formal removably insertable EMR conductionsystem.

The optical element further may comprise at least one optical featureselected from a group of optical features such as a reflective surface,an optically transmissible material, a lens, a fiber optic filament, andany combination thereof. The optical element also may be capable oftransmitting more than one wavelength or intensity EMR, for example, theoptical element may comprise one or more elongate bodies, with eachelongate body transmitting a different wavelength and/or intensity ofEMR. Multiple wavelengths may be transmitted alternatively,simultaneously, alternatively, or in tandem, or a combination thereof(for example, one constantly on and the other wavelength pulsed).Multiple intensities may be transmitted through the same elementsimultaneously. Alternating patterns of light treatments may also betransmitted.

The EMR conduction system may be configured to insert, at leastpartially, into one of any number of tubular structures such ascatheters, that as by way of example only and not to be limiting,includes a central venous catheter, a peripheral insertion catheter, aperipheral insertion central catheter, a midline catheter, a jugularcatheter, a subclavian catheter, a femoral catheter, a cardiac catheter,a cardiovascular catheter, a urinary Foley catheter, an intermittenturinary catheter, an endotracheal tube, a dialysis catheter with orwithout extension tubing connected thereto (whether hemodialysis orperitoneal dialysis (see FIGS. 14A to 22A)), a gastrointestinalcatheter, a nasogastric tube, a wound drainage catheter, or any similaraccessing medical catheter or tube that has been inserted into a patientor is connected to a catheter or tube for the purpose of delivering orretrieving fluids or samples via an inserted catheter or tube.

One exemplary embodiment of the EMR conduction system has an opticalelement comprising a single, insertable optical fiber. With a singleoptical fiber, the single fiber may allow light to transmit radially oraxially at various sections along its length. For sections where lightwill transmit radially, the exterior surface of the optical element maybe altered to facilitate the radial emission of the EMR. The alterationof the exterior surface may be achieved by chemical etching, physicaletching, or electromagnetic ablation through plasma or lasers to createvarious radial emission portions along the length of the optical fiber.The radial emission portions permit light to emit radially from theoptical fiber. Of course, another exemplary embodiment of the EMRconduction system may comprise multiple single, insertable opticalfibers, each being of the same length or differing lengths, or insertedpartially or fully into a catheter or a catheter extension.

For purposes of this disclosure, light emitted radially means that thelight has a radial component. Hence, the light emitted radially may emitperpendicularly and/or obliquely to the central axis of the opticalfiber at the axial point of emission.

For embodiments having radial emission sections, the material comprisingthe optical fiber may be selected from a group of materials comprisingoptical fibers including plastic, silica, fluoride glass, phosphateglass, chalcogenide glass, and any other suitable material that iscapable of axial light propagation and surface alteration to achieveradial emission. In addition, the optical fibers may be single mode,multi-mode, or plastic optical fibers that may have been optimized foralteration using a chemical, physical, or electromagnetic manufacturingalteration process. The optical fibers may also be optimized foralteration post-production.

Yet another exemplary embodiment employs a physical abrasion method ofalteration to modify the EMR conduction system comprised of at least oneoptical fiber. This fiber would be utilized based on its optimal opticalresponse to the physical abrasion process. This process may include, butis not limited to, sanding, media blasting, grinding, or buffing atleast one section of the optical fiber. The physical abrasion processwould also necessarily be optimized in terms of the extent of physicalabrasion to optimize the appropriate radial EMR emission or lackthereof. This may be accomplished by adjusting at least one of velocity,acceleration, pressure, modification time, or abrasion material utilizedin modifying the optical fiber.

Yet another exemplary embodiment employs microscopic porous structuressuspended within the optical fiber to achieve radial transmission oflight. These microscopic structures may be positioned within the coreand/or core-cladding boundary of the optical fiber. The microscopicstructures having a refractive index lower than the region free ofmicroscopic structures. The microscopic structures may be a materialadded to the optical fiber core or the core-cladding boundary, such as ametal, rubber, glass, or plastic. The microscopic structures may also bethe lack of material creating an aberration within the optical fibercore or the core-cladding boundary. For example, the presence ofmicroscopic bubbles in the optical fiber core would create an aberrationor imperfection that would alter the materials refractive index,resulting in EMR being emitted radially from the optical fiber.

Another exemplary embodiment may comprise at least one optical fiberwith cladding altered to optimize the radial or axial propagation ofEMR. For example, the cladding may be altered to at least partiallyremove or thin the cladding to achieve partial radial transmission ofEMR. Another example could include an optical fiber with only certainportions containing cladding, the EMR transmitting axially in the cladportions and at least partially axially and radially in the non-cladportions.

Yet another exemplary embodiment achieves uniform radial transmissionwherein the radial emission portion of the optical fiber hassubstantially equivalent intensity over the length of the radialemission portion along the optical fiber. This may be done throughchemical etching, physical etching, plasma ablation, or laser ablationin a gradient pattern. By altering at least one of velocity,acceleration, pressure gradients, flow, modification time, ormodification material or process, it is possible to achieve radialtransmission equivalency throughout each portion or the entire length ofthe modified optical fiber. During manufacturing, a gradient-provideduniformity also may be achieved through addition of microscopicstructures positioned within the core and/or core-cladding boundary in agradient pattern. Also, radial transmission uniformity achieved throughgradient cladding or core features are contemplated for achievingdesired radial emission, whether substantially uniform over a portionlength or varying as desired.

Still another exemplary embodiment achieves a gradient radialtransmission wherein at least one portion of the optical fiber emits EMRradially in a gradient distribution. The gradient distribution may alsobe accomplished through chemical etching, physical etching, plasma orlaser ablation in a uniform or gradient pattern. By altering at leastone of velocity, acceleration, pressure gradients, flow, modificationtime, or modification material or process, it is possible to achieve agradient radial transmission throughout a portion of the optical fiber.This may also be achieved through addition of microscopic structurespositioned within the core and/or core-cladding boundary. Gradientradial transmission enables another exemplary embodiment to exhibitcontrolled relative intensity that may be uniform over a portion of thelength and/or non-uniform and varying as desired.

A further exemplary embodiment of a removably insertable EMR conductionsystem comprises an optical element such as at least one LED, itsassociated wiring components, and a scaffold. The LED(s) may emit EMRbased on the LED’s inherent distribution, or may utilize another opticalelement, such as a lens or mirror, to focus or diffuse the EMR in thedirection of interest. In addition, more than one LED could be arrangedin an array to appropriately emit EMR for maximal therapeutic benefit.The LED(s), together with associated wiring components may bepermanently or removably attached to the scaffold, which allows forremovable insertion of the EMR conduction system into a catheter. Thescaffold may be rigid, semi-rigid, malleable, elastic, or flexible, orany combination thereof.

In another exemplary embodiment, a catheter with multiple lumens forfluid injection or retrieval contains one or more separate lumens fortransmission of the therapeutic EMR. Each lumen may have a separateproximal catheter hub assembly. These internal lumens converge at aconvergence chamber, where individual internal lumens consolidate into asingle elongated catheter body while retaining their individual internalpaths. Such exemplary device may include use of an optical method fordiverting the radiation between the convergence chamber and axiallythrough the designated catheter internal lumen.

Samples retrieved through the distal end are often used to characterizethe type of infection. One exemplary embodiment of the disclosurefocuses on maintaining axial propagation of the light relative to thecatheter and delivering therapeutic light of sufficient intensity to thedistal end of the catheter to prevent, reduce or eliminate the count ofinfectious agents residing thereon.

In yet another exemplary embodiment, the medical device assembly wouldbe used in a urological setting. The catheter (such as a Foley catheter)would be placed into the urethra and bladder of the urinary tract.

In yet another exemplary embodiment, the medical device assembly wouldbe used in a gastrointestinal setting.

In yet another exemplary embodiment, the medical device assembly wouldbe used in an intravascular setting.

In yet another exemplary embodiment, the medical device assembly wouldbe used within the cranial cavity of a patient.

In yet another exemplary embodiment, the medical device assembly wouldbe used within the spinal cavity of a patient.

In still another exemplary embodiment, the medical device assembly wouldbe used within an ophthalmic cavity of a patient.

In still another exemplary embodiment, the medical device assembly wouldbe used within a dialysis catheter with or without extension catheter(s)and/or connector(s) (whether hemodialysis or peritoneal dialysis).

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the invention will become more fully apparentfrom the following description and appended claims, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly exemplary embodiments and are, therefore, not to be consideredlimiting of the invention’s scope, the exemplary embodiments of thepresent disclosure will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1 is a perspective frontal view of an exemplary embodiment of alight engine box showing various features accessible from the frontpanel overlay of the light engine box, including a laser aperture, abattery power indicator, RFID feature, a light test aperture, treatmenton/off actuator, and alarm features.

FIG. 2 is a perspective rear view of the exemplary embodiment of a lightengine box showing various features accessible from the back panel ofthe light engine box, including an on/off switch and power ports.

FIG. 3 is an exploded perspective view of an exemplary embodiment of alight engine box showing various component parts, including a laserassembly, a central processing unit (CPU), a battery assembly, a sideport test module, a front overlay, and a front panel with dust covers.

FIG. 4 is a perspective frontal view of another exemplary embodiment ofa light engine box having an on/off switch on the front panel overlayand with an umbilical light transmission cable connected to the lightengine box through the laser aperture and ready for use.

FIG. 5 is a perspective frontal view of the exemplary embodiment of thelight engine box of FIG. 1 having an umbilical light transmission cableconnected to the light engine box through the laser aperture, showingthe umbilical light transmission cable in a light testing mode.

FIG. 6 is an exploded perspective view of an exemplary embodiment of anumbilical light transmission cable showing various components, includinga distal connector and a proximal connector.

FIG. 7 is a perspective vertical section of the distal connector of theexemplary embodiment of the umbilical light transmission cable of FIG. 6.

FIG. 8 is a perspective horizontal section of the proximal connector ofthe exemplary embodiment of the umbilical light transmission cable ofFIG. 6 .

FIG. 9 is a plan view of an exemplary embodiment of a fiber opticdisposable.

FIG. 10 is a plan view of an exemplary embodiment of packaging for thefiber optic disposable of FIG. 9 , showing the fiber optic disposabledisposed within the packaging.

FIG. 11 is an exploded view of the fiber optic disposable of FIG. 9 ,showing various component parts thereof.

FIG. 11A is an exploded view of an exemplary check valve shown as one ofthe components of the fiber optic disposable of FIG. 9 .

FIG. 11B is a reversed perspective view of an exemplary ferrule assemblyshown as one of the components of the fiber optic disposable of FIG. 9 .

FIG. 11C is an exploded perspective view of the exemplary ferruleassembly shown as one of the components of the fiber optic disposable ofFIG. 9 , showing various components of the ferrule assembly.

FIG. 11D is a reversed perspective view of an exemplary ferrule covershown as one of the components of the fiber optic disposable of FIG. 9 .

FIG. 12 is a plan view of an exemplary fiber optic introducer showingport connectors for connecting to an extension set, the distal connectorvia a fiber optic disposable, and a PD catheter, respectively.

FIG. 13 is a plan view of an assembly of the exemplary fiber opticintroducer, the extension set, the distal connector, the fiber opticdisposable, and the PD catheter, respectively, showing light emissionwithin the extension set, the fiber optic introducer, and the fiberoptic disposable.

FIGS. 14A-C is a series of perspective views of an exemplary two-cuffperitoneal dialysis catheter illustrating exemplary radial EMRemissions; FIG. 14A is a perspective view of an exemplary two-cuffperitoneal dialysis catheter showing the radial emission extending froma connector hub and a point proximate to and downstream from theperitoneal cuff; FIG. 14B is a perspective view of another exemplarytwo-cuff peritoneal dialysis catheter showing the radial emission of EMRbetween a point upstream of the subcutaneous cuff and a point downstreamof the peritoneal cuff; and FIG. 14C is a perspective view of yetanother exemplary two-cuff peritoneal dialysis catheter showing theradial emission of EMR between the connector hub and a point within aperitoneal dialysis solution region.

FIG. 15A is an elevation view of an exemplary two-cuff peritonealdialysis catheter with an extension set interface showing radial EMRemission in the Y-site/transfer region only.

FIG. 15B is an elevation view of the two-cuff peritoneal dialysiscatheter 10 connected to the extension set interface, showing radial EMRemission only exterior to the patient’s body.

FIG. 15C is an elevation view of another exemplary two-cuff peritonealdialysis catheter with an extension set interface showing radial EMRemission in the Y-site/transfer region, a connector hub region, atunneled segment, and within the peritoneal dialysis solution region.

FIG. 15D is an elevation view of still another exemplary two-cuffperitoneal dialysis catheter with an extension set interface showingradial EMR emission in the Y-site/transfer region, a connector hubregion, a tunneled segment, and within the peritoneal dialysis solutionregion extending into the coiled Tenckhoff.

FIG. 16A is a schematic view of an exemplary embodiment of a single-cuffperitoneal dialysis catheter as connected to a light engine box via anumbilical light transmission cable and as inserted within a femalepatient’s body.

FIG. 16B is a schematic view of another exemplary embodiment of asingle-cuff peritoneal dialysis catheter as connected to a light enginebox via an umbilical light transmission cable and as inserted within afemale patient’s body showing radial EMR emission received from a pointdownstream of the EMR source to just downstream of the peritoneal cuffand within the peritoneal dialysis solution region.

FIG. 17 is a schematic view of an exemplary embodiment of a peritonealdialysis system showing dialysate supply and return bags and aperitoneal dialysis catheter as connected to a light engine box via anumbilical light transmission cable to supply EMR for emission at andproximate the catheter entry site.

FIG. 18 is a schematic view of a portion of an exemplary embodiment of aperitoneal dialysis system showing the emission of EMR at a treatmentlocation in a PD extension catheter and into a dialysate exchangeswitch.

FIG. 19 is a schematic view a portion of another exemplary embodiment ofa peritoneal dialysis system depicting dual EMR delivery.

FIG. 20 is a schematic view of still another exemplary embodiment of aperitoneal dialysis system depicting another exemplary dual EMR deliveryusing two light engine boxes and two umbilical light transmissioncables.

FIG. 21 is a schematic view of yet another exemplary embodiment of aperitoneal dialysis system depicting dual EMR delivery using a singlelight engine box with dual laser apertures.

FIG. 22 is a schematic view of a representative exemplary embodiment ofa hemodialysis system depicting a hemodialysis unit shown in phantomlines, components of the dialysis system pertinent to the invention ofthis disclosure, and an inset area enlarged as FIG. 22A.

FIG. 22A is an enlargement of the inset area identified in FIG. 22showing an exemplary dialysis access into the arm of a patient.

REFERENCE NUMERALS (smart) light engine system 10 light engine box 12front panel overlay 14 laser aperture 16 battery power indicator 18 RFIDfeature 20 light test aperture 22 treatment on/off actuator 24 alarmfeatures 26 back panel 28 on/off switch 30 power ports 32 laser assembly34 central processing unit 35 battery assembly 36 side port test module38 front panel 40 dust covers 42 umbilical light transmission cable 44venting features 46 user interface 48 warning icons 50 alarm alert 52alarm on/off actuator 54 side port test adapter 56 cable adapter or SMAadapter 58 distal connector 60 proximal connector 62 cable 64 fiberoptics 66 wire(s) 68 cable sleeve 70 first optical interlock 72 opticalinterlock connector 74 proximal SMA 76 securement magnet(s) 78 proximalconnector shell 80 extended forward edge 81 SMA adapter 82 secondoptical interlock 84 press-in ball joint(s) 86 distal SMA 88 distalconnector shell 90 front cover 92 pins 94 fiber optic disposable 96optical fiber 98 collapsible/retractable sleeve 100 proximal end 102distal end 104 packaging 106 RFID adhesive tag 108 face seal blisterpackaging 110 see-through blister face 112 opaque backing 114 barrel 116female luer adapter 118 male luer plug 120 check valve 122 capture ring124 check valve body 126 check valve disk 128 a check valve cap 130central bore 132 barrel plug 134 barrel plug cap 136 ferrule 138magnetic washer 140 ferrule cap 142 optical fiber receiving bore 144reinforced end 146 fiber optic introducer 148 main line 150 entry port152 exit port 154 branching line 156 side port 158 clamp 160 sealingcap(s) 162 extension set 164 PD catheter 166 connector hub 168peritoneal cuff 170 subcutaneous cuff 172 coiled Tenckhoff 174 externalregion 176 tunneled region 178 exit site location 180 intra-peritonealregion 182 peritoneal dialysis solution region 184 extended PD catheterassembly 186 Y-port adapter 188 extension line tubing 190 connectingluer 192 Y-site/transfer region 194 extension set region 196 connectionhub region 198 holes 200 peritoneal dialysis solution 202 patient’s body204 peritoneal dialysis system 206 fluid extension line 208 dialysateexchange switch 210 dialysate supply bag 212 waste dialysate retrievalbag 214 extension connector 216 extension line portal 218 dialysateinlet 220 waste dialysate outlet 222 exchange selector 224 feed line 226waste dialysate 228 introducing adapter 230 drainage line 232 receiveradapter 234 line clamp 236 dual introducing multi-direction adapter 238dialysis access 240 hemodialysis system 300 hemodialysis unit 302dialyzer 304 blood pump 306 dialysate reservoir 308 waste dialysatereservoir 310 saline bag 312 heparin pump 314 air trap/air detector 316arterial-pressure monitor 318 venous-pressure monitor 320inflow-pressure monitor 321 inbound blood flow tubing 322 outbound bloodflow tubing 324 outbound venous line (venous access) 326 inboundarterial line (arterial access) 328 saline line 330 feed line 332drainage line 334 Arrow A Arrows B Flow Arrows C Inflow Arrow D DrainageArrow E

DETAILED DESCRIPTION

Exemplary embodiments of the present disclosure will be best understoodby reference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the exemplary embodiments, as generally described and illustrated inthe Figures herein, could be arranged and designed in a wide variety ofdifferent configurations. Thus, the following more detailed descriptionof the exemplary embodiments of the apparatus, system, and method of thepresent disclosure, as represented in FIG. 1 through 22A, is notintended to limit the scope of the invention, as claimed, but is merelyrepresentative of exemplary embodiments.

The phrases “attached to”, “secured to”, and “mounted to” refer to aform of mechanical coupling that restricts relative translation orrotation between the attached, secured, or mounted objects,respectively. The phrase “slidably attached to” refers to a form ofmechanical coupling that permits relative translation, respectively,while restricting other relative motions. The phrase “attached directlyto” refers to a form of securement in which the secured items are indirect contact and retained in that state of securement.

The term “abutting” refers to items that are in direct physical contactwith each other, although the items may not be attached together. Theterm “grip” refers to items that are in direct physical contact with oneof the items firmly holding the other. The term “integrally formed”refers to a body that is manufactured as a single piece, withoutrequiring the assembly of constituent elements. Multiple elements may beformed integral with each other, when attached directly to each other toform a single work piece.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

FIGS. 1-5 are directed to a light engine system 10 (in this case a smartlight engine system 10). FIG. 1 is a perspective frontal view of anexemplary embodiment of the smart light engine system 10 comprising alight engine box 12 showing various features accessible from a frontpanel overlay 14 of the light engine box 12, including a laser aperture16, a battery power indicator 18, RFID feature 20, a light test aperture22, treatment on/off actuator 24, and alarm features 26. FIG. 2 is aperspective rear view of the light engine box 12 of FIG. 1 showingvarious features accessible from a back panel 28 of the light engine box12, including an on/off switch 30 and power ports 32. FIG. 3 is anexploded perspective view of the smart light engine system 10 of FIG. 1showing various component parts, including a laser assembly 34, acentral processing unit (CPU) 35, a battery assembly 36, a side porttest module 38 having a photo diode (not shown), the front panel overlay14 and a front panel 40 with dust covers 42. Other component parts willbe referenced and described below.

FIG. 4 is a perspective frontal view of an alternative exemplaryembodiment of a light engine box 12 having the on/off switch 30 on thefront panel overlay 14 and showing an exemplary umbilical lighttransmission cable 44 connected to the light engine box 12 through thelaser aperture 16 and ready for use. The umbilical light transmissioncable 44 will be referenced and described below.

FIG. 5 is a perspective frontal view of the light engine box 12 of FIGS.1 and 4 having the umbilical light transmission cable connected to thelight engine box through the laser aperture, showing the umbilical lighttransmission cable 44 in a light testing mode by engagement through thelight test aperture 22. The nature of the connection and the lighttesting mode will be referenced and described below.

Of particular interest to each of the contemplated embodiments of thepresent invention, the use of light (EMR) may have wavelengths rangingfrom above 380 nm and about 904 nm. Additionally, the intensity andpower of the light emitted serves to inactivate infectious agents and/orto promote healing. A of radiant exposures covering 0.1 J/cm² to 5kJ/cm² (or in some instances up to 10 kJ/cm²), and a range of powersfrom 0.005 mW to 5 W (or in some instances up to 10 W), and powerdensity range covering 1 mW/cm² and 2 W/cm² (or in some instances up to5 W/cm²) are of interest for these exemplary device assemblies andmethods. These ranges of wavelengths, power densities, and radiantexposures have been shown to have either antimicrobial effects orpositive biological effects on healing tissue. These positive biologicaleffects include reduction of inflammatory cells, increased proliferationof fibroblasts, stimulation of collagen synthesis, angiogenesisinducement and granulation tissue formation.

For each exemplary embodiment described herein, each laser assembly 34,its delivery mechanism, and the delivery method for disinfecting/healingmay be utilized and controlled manually or by a CPU 35 to provide anadjustable or predetermined duty cycle. If treatments begin immediatelyafter sterile procedure has been initiated or in some instances, iftreatments proceed during a sterile procedure, device-related infectionsmay be prevented, inhibited, or eliminated. This includes device-relatedbiofilm growth. For example, the EMR delivery system may provide oneduty cycle for preventing device-related infections prior to beginningdialysis and another different duty cycle for during the dialysisprocess, or one duty cycle may be tailored for females and anotherdifferent duty cycle may be tailored for males. With the use of the CPU35 that is pre-programmed or programmable, many different types of dutycycles may be stored within the CPU’s memory for recall and use whenappropriate. Such different types of duty cycles may differ by differentparameters such as wavelength, intensity, and duration having differingvalues within the ranges disclosed herein or by having different dosingtechnique parameters (for example, the HISD technique, discussed below,differs from a steady non-changing dose for a given time duration).

Additionally, although a wavelength in a range from 380 nm to 904 nmwith a sufficient intensity will inactivate one or more infectiousagents and/or enhance healthy cell growth, more precise wavelengths mayhave enhanced efficacy against certain infectious agents or for adesired healing purpose. It has been determined that sterilizing EMR ofwavelengths including wavelengths centered about 400 nm, 405 nm, 415 nm,430 nm, 440 nm, 455 m, 470 nm, 475 nm, 660 nm, and 808 nm have efficacy.A wavelength selected to promote healing and healthy cell growth may beselected from the group of wavelengths centered about 632 nm, 632.8 nm,640 nm, 650 nm, 660 nm, 670 nm, 680 nm, 780 nm, 808 nm, 830 nm, and 904nm.

Because dosing techniques may differ with different intended uses, theinvention of this disclosure provides the versatility that mayaccommodate different uses and different dosing techniques, particularlywhen programmable into and controlled by an internal CPU 35. Forexample, if the intended use is to deliver EMR to sterilize an extensionset or a coupling disposed outside of a patient’s body the power of andexposure to the EMR may be more aggressive than might be the case if theEMR delivered is for preventing, inhibiting, or eliminating infectiousagents within the patient’s body a more moderate EMR may be used.Additionally, if there is a time constraint that may be advantageous tothe user/patient that may be met or optimized by a High Intensity -Short Duration (HISD) technique, for which the invention of thisdisclosure is particularly suitable, whereas a lower power administeredover a longer period may also be administered using the invention ofthis disclosure.

The HISD technique can be effective in preventing, inhibiting, andeliminating particularly stubborn infectious agents. For example, a35-minute treatment using two 1 W laser diodes may be administered up toa radiant exposure of 270 mW/cm² which equates to approximately 570J/cm². This type of treatment may be used outside the patient’s bodybefore starting dialysis, while a less aggressive 4-hour treatmentdelivering EMR inside the patient’s body may use the same light enginebox 12. It is contemplated that 20-minute treatments that are slightlymore aggressive than a 35-minute treatment may be used in some instancesand will be very advantageous to dialysis patients, reducing totalconnect time with the dialysis system and adding in-home convenience andcomfort.

In short, the invention of the present disclosure may provide an avenuefor thousands of dialysis patients to receive competent and safetreatment at home for a fraction of the cost in time, money, comfort,and convenience of clinic and/or hospital administered dialysis. Ofcourse, the invention of the present disclosure may be used in someclinic and hospital settings and is not limited to dialysis use.

Turning now to FIG. 1 with specific reference to the smart light enginesystem 10 and enclosed within and presented by the light engine box 12,the light engine box 12 is displayed as a substantially rectangular boxwith soft-rounded edges for comfortable handling and has ventingfeatures 46 to assist in the dissipation of heat that may be generatedby the smart light engine system 10. The front panel 40 has the frontpanel overlay 14 connected thereto to present a user interface 48 makingvarious features and connections available to a user/patient in theoperation of the smart light engine system 10. The front panel overlay14 may present to the user/patient warning icons 50, the laser aperture16, the battery power indicator 18, the RFID feature 20 indicator, thelight test aperture 22, the treatment on/off actuator 24, and alarmfeatures 26.

Although the drawings and description herein are directed to a smartlight engine system, of course, a light engine system that does not haveany of the versatility features shown and discussed herein is alsocontemplated. For example, a laser assembly 34 may be factory preset toa particular wavelength and intensity that provides a duty cycleregulated by an on/off switch that determines duration of use.

The laser aperture 16 provides connection access of the proximal end ofthe umbilical light transmission cable 44 directly to the laser assembly34 through the dust covers 42. The dust covers 42 inhibit handling anddust contamination of the connection environment between the umbilicallight transmission cable 44 and the laser assembly 34 (shown in FIG. 3), thereby maximizing the efficiency of light (EMR) transmittal from theEMR source into the umbilical light transmission cable 44.

Best shown in FIG. 3 is a schematic depiction of a central processingunit (CPU) 35 that controls features provided by the smart light enginebox such as those that are displayed on the front panel overlay 14;namely, for example, the battery power indicator 18, the RFID feature20, the treatment on/off actuator 24, and the alarm features 26. The CPU35 is connected to the power supply (battery and/or power outlet) and ispre-programmed and/or programmable. The operation of the CPU 35 tocontrol the features disclosed herein is within the experience andknowledge of those skilled in the art once armed with the disclosuresand teachings of this specification. Consequently, the specificcircuitry and wiring is not shown so that the components of the EMRdelivery system are not unnecessarily obscured.

The battery power indicator 18 may provide a visual indication to theuser/patient of the status of the battery charge capability of thebattery assembly 36. The battery assembly 36, best shown in FIG. 3 , isprovided to maintain operability of the smart light engine system 10 ifpower from an institutional power source (for example, a power outlet ora generator) is interrupted, lost, or unavailable. Hence, the batteryassembly 36 may serve as a safety backup feature or a rechargeablebattery may provide the principal power source with the battery powerindicator 18 alerting the used when recharging is needed. The batterypower indicator 18 arms the user/patient with power-related informationand peace of mind that the smart light engine system 10 will properlyoperate through a complete treatment cycle, even if the power source isinterrupted, lost, or unavailable for any reason.

The RFID feature 20 indicator is the interface used for monitoring andtracking use of a disposable component (to be referenced and describedbelow) used to facilitate sterile connection of the umbilical lighttransmission cable 44 to a catheter such as, for example, a peritonealdialysis catheter (“PD catheter”) by the user/patient to prevent overuseof the disposable component. The RFID feature 20 has a RFID reader witha built-in antenna (not shown) that enables reading of RFID tags whenplaced near to the RFID feature 20 indicator. The CPU 35 communicateswith the RFID reader to facilitate acknowledgement of the disposablecomponent, monitor the use of the disposable component, and to activatean alert indicating that, for example, the disposable component isunable to complete another treatment before the predetermined usefullife of the disposable component is exhausted.

The light test aperture 22 provides connection access of the distal endof the umbilical light transmission cable 44, through the dust covers42, directly to the side port test module 38. The dust covers 42 inhibithandling and dust contamination of the connection environment betweenthe umbilical light transmission cable 44 and the side port test module38 (shown in FIG. 3 ), thereby providing the ability to test the lightemanating from the umbilical light transmission cable 44 to verify thatit is the desired EMR (wavelength and intensity) for the intendedtreatment and the ability to determine the health of the laser diodewithin the laser assembly 34 and any degradation in the lighttransmission of the umbilical light transmission cable 44, suggestingthat either or both should be replaced. The CPU 35 communicates with thetest module to facilitate testing of the EMR. The test module 38 sendstest results to the CPU 35 to be analyzed against predetermined EMRparameters by comparing the tested EMR parameters to the desired EMRparameters so that the CPU 35 may determine the health of the laserdiode within the laser assembly 34 and if there is any degradation inthe light transmission of the umbilical light transmission cable 44 sothat an alert may be activated indicating that, for example, theumbilical light transmission cable 44 has degraded and replacement isrecommended or that the laser diode’s useful life has been exhausted.

The treatment on/off actuator 24 may be a push button interface foractuation by the user/patient that, when actuated, initiates apre-programmed or program selected duty cycle of EMR at prescribedwavelength(s), intensity(ies), and duration or interval(s) as stored inthe CPU 35. The duty cycle may terminate automatically per theprograming, or it may be terminated manually (e.g., by pushing thebutton interface) in the event of a justifiable need to terminate.Again, with the CPU 35 that is pre-programmed or programmable, manydifferent types of duty cycles may be stored within the CPU’s memory forrecall and use when appropriate. Such different types of duty cycles maydiffer by different parameters such as wavelength, intensity, andduration having differing values within the ranges disclosed herein orby having different dosing technique parameters (for example, the HISDtechnique, discussed below, differs from a steady non-changing dose fora given time duration).

The alarm features 26 may comprise an alarm alert 52 that may be audibleand/or visible and an alarm on/off actuator 54. The alarm alert 52 maymake an audible sound (buzzing, ringing, speaking, and/or the like)and/or provide a visible alert (red/green light, flashing light, a readout, and/or the like). The alarm features 26 may provide feedbackregarding various aspects of the treatment experience. For example, thealarm alert 52 may display a green light or play a “ready for use”message when the testing of the light emanating from the umbilical lighttransmission cable 44 indicates that the light is ready for use in theintended treatment; or, the alarm alert 52 may display a red light orplay an error message when the testing of the light emanating from theumbilical light transmission cable 44 indicates that the light isdefective or not ready for use in the intended treatment. The alarmon/off actuator 54 may be used to turn on the visible alert to test thatit is operable, or it may be used to turn off an audible and/or visiblealert that has been triggered to alert the user/patient. Additionally,the alarm features 26 may be used to raise the awareness of theuser/patient to any operating aspects of the smart light engine system10. For example, actuating the alarm on/off actuator 54 during treatmentmay trigger the alarm alert to audibly provide that time remaining inthe treatment or some other operating aspect that is being monitored ortracked by the system 10 (for example, the amount of radiant exposure orthe amount of time remaining for the present disposable to be usedbefore replacement). Each of the alert features 26 discussed in thisparagraph and throughout this disclosure may be controlled by the CPU 35which is in communication with the alarm alerts 52 and variouscomponents that may trigger an alarm alert 52. Again, the design andoperation of the CPU 35 to control the alarm features disclosed hereinis within the experience and knowledge of those skilled in the art oncearmed with the disclosures and teachings of this specification.

The venting features 46 may comprise a series of holes as shown in FIG.1 on one of the side panels, but such venting features may be slots orvents and may be located anywhere on the exterior of the light enginebox 12 that will facilitate the dissipation of heat within the smartlight engine system 10. For example, though some are not shown in thefigures, the venting features 46 may be located on the back panel 28,the side panels, the top panel, or the bottom panel.

The warning icons 50 may be of any type that provide information to theuser/patient. The smart light engine system 10 is a medical device thathas operating components that may be harmful to persons or theenvironment if mishandled. The warning icons 50 may provide cautions,instructions, and/or use of product warnings directed at theuser/patient. Exemplary warning icons 50 are shown generically as decalsand labels on the front panel overlay 14 of FIG. 1 and the back panel 28of FIG. 2 .

The back panel 28 of the light engine box 12, best shown in FIG. 2 , maypresent a second user interface 48 making various features andconnections available to a user/patient in the operation of the smartlight engine system 10. The back panel 28 may present to theuser/patient, for example, warning icons 50, the on/off switch 30, andpower ports 32. The on/off switch 30 may be the general on/off thatcontrols the power being supplied to the light engine box 12 from aninstitutional source and/or the power being drawn from the batteryassembly 36. In FIG. 2 , the on/off switch 30 is located on the backpanel 28, however, the on/off switch 30 may be located at any otherconveniently accessible location on the exterior of the light engine box12. For example, as shown in FIG. 4 , or on either side panel or the toppanel.

The power ports 32 may be of any type. Two such power ports 32 are shownin FIG. 2 as female adapters for receiving complementary power cords, byway of example, and to demonstrate that the system 10 may achieve moreversatility of use by having multiple types of power ports 32. Ofcourse, however, it is also contemplated that just a single power port32 and/or a hard-wired power cord may be used to provide power to thelight engine box 12.

Because FIG. 3 is an exploded view of an exemplary smart light enginesystem 10, various exemplary internal components are shown. As depicted,the exemplary smart light engine system 10 comprises the front paneloverlay 14, the front panel 40 with dust covers 42, the laser assembly34, the CPU 35, the battery assembly 36, the side port test module 38, aside port test adapter 56, a cable adapter 58, and various othercomponents used in the alignment and assembly of components of the lightengine box 12.

Although one laser assembly 34 is shown in FIG. 3 , multiple laserassemblies 34 may be used to accomplish various capabilities by thelight engine box 12. One laser assembly 34 may provide a certainwavelength at a certain intensity and a second identical laser assembly34 may be configured to operate in tandem with the other laser assemblyto provide EMR with the same wavelength and about double the intensity.For example, two NovaLum lasers (manufactured by Ushio America, Inc. ofCypress, California) operating at 1W each at a given wavelengthconfigured in tandem may produce EMR emitting at the given wavelength atabout 2W. Additionally, multiple laser assemblies 34 may provide thesame wavelength and intensity to multiple umbilical light transmissioncables 44 or differing wavelengths and intensities to a single ormultiple umbilical light transmission cables 44.

The laser assembly 34 may have other operating capabilities. Suchoperating capabilities are known in the art but have not been usedpreviously in an EMR delivery system as disclosed herein to disinfectand/or heal. For example, a laser assembly 34 may operate at a singlewavelength for dedicated purpose or the wavelength may be adjustable andtunable from one wavelength to another, or the wavelength may be tunableonly within a predetermined wavelength range (such as the blue lightrange or the range of 380 nm to 904 nm as disclosed herein). Also, asingle laser assembly 34 operate to provide multiple wavelengths at thesame time such as a disinfecting wavelength simultaneously with adifferent disinfecting wavelength and/or a healing wavelength.

One embodiment of the light engine box 12 has the laser assembly 34disposed proximate or abutting the front panel 40 so that the umbilicallight transmission cable 44 connects directly into the laser assembly 34via a SMA adapter 58 (subminiature version A optical fiber connector)and may be connected directly into the side port test module 38 via aSMA adapter 58 as will be described below. The direct connectioneliminates undesirable light bleed or loss so that the light produced bythe laser assembly 34 and entering the umbilical light transmissioncable 44 is identical or virtually identical to the light emanating fromthe distal end of the umbilical light transmission cable 44 for use intreatment dosing or to be tested by a photo diode when connected to theside port test module 38. Hence, any meaningful difference in the lightbeing tested from the light produced accurately senses and measures thehealth of the laser diode in the laser assembly 34 and any degradationof the umbilical light transmission cable 44 over time as the umbilicallight transmission cable 44 is repeatedly used during treatments andtested periodically before each treatment, as recommended. Theuser/patient may, with confidence, maximize the useful life of theumbilical light transmission cable 44 and know precisely when it shouldbe replaced so not to compromise dosing treatments.

FIG. 4 and FIG. 5 show exemplary light engine boxes 12 in the “ready touse” mode and the “testing” mode, respectively. By connecting theumbilical light transmission cable 44 to the laser assembly 34 throughthe laser aperture 16 the EMR (light) is transmitted from the laserassembly 34 to a wide range of remote locations that facilitates use ofthe light engine system 10 within institutional (hospital, clinic, etc.)and home-use settings. The light engine system 10 enables a range ofmobility during the sterilizing operation and/or during treatment,making the experience much more comfortable and efficacious for in-hometreatments that heretofore have not been possible, thereby dramaticallyreducing catheter related infections (CRIs), medical costs and insurancecosts while providing convenience and comfort to the patients receivingtreatments.

FIGS. 6-8 are directed to the component parts and operation of anexemplary umbilical light transmission cable 44. The exemplary umbilicallight transmission cable 44 depicted has several features in addition tothe axial delivery of EMR. Of course, those skilled in the art, enabledby this disclosure, may make, and use umbilical light transmissioncables 44 with more or lesser features or achieve axial delivery of theEMR without departing from the scope and spirit of the inventiondisclosed in this application.

FIG. 6 is an exploded perspective view of an exemplary embodiment of anumbilical light transmission cable 44 showing various components,including a distal connector 60, a proximal connector 62 and a cable 64therebetween. The cable 64 comprises fiber optics 66, wire(s) 68 and acable sleeve 70. The proximal connector 62 comprises a first opticalinterlock 72 with an optical interlock connector 74, a proximal SMA 76,securement magnet(s) 78, and a proximal connector shell 80 with anextended forward edge 81(best shown in FIG. 8 below). The distalconnector 60 comprises a SMA adapter 82 having a second opticalinterlock 84 with press-in ball joint(s) 86, a distal SMA 88, a distalconnector shell 90, and a front cover 92. These interlocking featuresprovide safe and secure connections to prevent undesired disconnectionthat may permit randomly directed laser light, undesired lightscattering, or insufficient light for disinfection.

The cable 64 of the umbilical light transmission cable 44 may be of anysuitable length and be manufactured to various standard lengths suitablefor differing uses. For example, the length of cable 64 for in-hospitalused may be shorter than the cable 64 designed for in-home use where thepatient is likely more mobile. The fiber optics 66 may be a single fiberor a bundle of fibers, as needed, and may have negligible or minimalattenuation to minimize or virtually eliminate light loss while axiallypropagating through the fiber optics 66. The wire(s) 68 may betransmission wire(s) used for the transmission of data or electricitythe facilitate the smart features of the smart light engine system 10 orto provide downstream electrical power where needed.

FIG. 7 depicts a vertical section of the distal connector 60 of theumbilical light transmission cable of FIG. 6 fully assembled with thewire(s) 68 truncated so not to obstruct view of other internalcomponents. The fiber optics 66 are shown securely connected and alignedwith the distal SMA 88 nested securely within the SMA adapter 82 andlocked into position by the second optical interlock 84 so that a properconnection and alignment is maintained, and light loss is minimized oreliminated at the connection juncture. These internal components areencased within the distal connector shell 90 and the front cover 92 tokeep the interior components free of contaminants such as dust andmoisture. As depicted, the distal connector 60 may be connected to theside port test module 38 or other downstream implements such as adisposable, a connector, or a catheter to facilitate the furthertransmission of EMR. Examples of such downstream implements will bedescribed below.

FIG. 8 depicts a vertical section of the proximal connector 62 of theexemplary umbilical light transmission cable 44 of FIG. 6 fullyassembled again with the wire(s) 68 truncated so not to obstruct view ofother internal components. The proximal connector 62 has an extendedforward edge 81 that engages and opens the dust cover 42 doors (thatswing open inwardly) to protect the polished fiber optics 66. The fiberoptics 66 are shown securely connected and aligned with the proximal SMA76 securely positioned and locked into position by the first opticalinterlock 72 so that a proper connection and alignment is maintained,and light loss is minimized or eliminated at the connection juncture.The wire(s) 68 (though shown as truncated) may be attached to pins 94 tofacilitate the transmittal of data and/or electrical power from thelight engine box 12 to the umbilical light transmission cable 44 forfurther transmission downstream of the umbilical light transmissioncable 44. The securement magnets 78 provide magnetic resistance todislodging the connection between the light engine box 12 and theproximal connector 62 so that alignment and connection is notcompromised inadvertently. To disengage the proximal connector from thelight engine box 12 requires a pulling force that overcomes bothfrictional and magnetic resistance. These internal components areencased within the proximal connector shell 80 and the optical interlockconnector 74 to keep the interior components free of contaminants suchas dust and moisture.

FIG. 9-11D are directed to the component parts and operation of anexemplary fiber optic disposable 96 that is notable for its ease of usewhile maintaining system sterility. The exemplary fiber optic disposable96 has an elongate structure comprising an optical fiber 98 enclosedwithin a collapsible/retractable sleeve 100 and disposed between aproximal end 102 and a distal end 104. The fiber optic disposable 96 maybe constructed to various overall lengths to accommodate the desiredlength of optical fiber 98 to be advanced into sterilizing positionwithin a tubular structure such as a catheter, extension line tube, andthe like.

FIG. 9 depicts the exemplary fiber optic disposable 96 in its unused orfully retraced mode detached from connection to the umbilical lighttransmission cable 44 and any downstream connection. As depicted, theoptical fiber 98 is enclosed within the collapsible/retractable sleeve100 that provides a sterile environment inside thecollapsible/retractable sleeve 100 between the proximal end 102 and thedistal end 104 that serve to seal the ends of thecollapsible/retractable sleeve 100 to encapsulate and preserve thesterile environment. In an exemplary embodiment of the fiber opticdisposable 96, the collapsible/retractable sleeve 100 may be formed of aflexible, gas-impermeable polyethylene (PE) plastic and/or the opticalfiber 98 may be plastic.

FIG. 10 is a plan view of an exemplary embodiment of packaging 106 forthe fiber optic disposable 96 of FIG. 9 , showing the fiber opticdisposable 96 disposed within the packaging and an RFID adhesive tag 108(shown in phantom lines) attached to the exterior surface of thepackaging 106. The packaging 106 may be of any suitable type thatmaintains the sterility of the fiber optic disposable during transportand storage. The exemplary packaging 106 depicted is face seal blisterpackaging 110 comprising a see-through blister face 112 and an opaquebacking 114. FIGS. 9 and 10 , show the fiber optic disposable in itsretracted mode.

By placing the RFID adhesive tag 108 within readable proximity to theRFID feature 20 indicator on the front panel overlay 14 of the lightengine box 12 the fiber optic disposable 96 within the packaging 106having the RFID adhesive tag 108 may be registered with the smart lightengine system 10 and initiate monitoring use of that specific fiberoptic disposable 96. Such monitoring helps prevent using fiber opticdisposables 96 that compromised by fluid over fiber degradation of theoptical fiber 98. Each fiber optic disposable 96 may have apredetermined useful life for safe and effective use; therefore,tracking the age of the optical fiber 98 and the accumulated time of usemay prevent an undesirable use of an optical fiber 98 that has beentime/use compromised. For example, depending on the nature of the use,the useful life may be determined to be a week to ten days and/or tenuses and/or no more than twenty-five total hours (similarly torecommended oil changes in a vehicle being at three months or 3,000miles intervals). The monitoring and tracking performed by the smartlight engine system 10 may determine how long, how many uses, and/or howmuch total use duration is acceptable for the proper use of the fiberoptic disposable and activate notice to the user/patient when the in-usefiber optic disposable 96 has expired and needs to be replaced with afresh fiber optic disposable 96. The activated notice may take anysuitable form; for example, the alarm alert 52 may provide audibleand/or visual alert(s), the treatment on/off actuator may be disabled,and/or the laser assembly 34 may be disabled until a fresh replacementfiber optic disposable 96 is registered via the scanning of its RFIDadhesive tag 108 at the RFID feature 20 of the light engine box 12.

These registering, monitoring, and replacement noticing capabilities are“smart” features of the smart light engine system 10. Any given lightengine box 12 may not have any or each of these “smart” features but mayhave one or more other “smart” features (such as the “smart” featuresthat determines and provides notice of a tired laser diode and/ordegradation of the umbilical light transmission cable 44 describedabove). In fact, a light engine box 12 is not required to have any ofthe smart features disclosed herein so long as it capably delivers EMRfor use to prevent, reduce, or eliminate infectious agents in a catheteror in a catheter extension or catheter connections. However, theefficiency and efficacy of preventing, reducing, or eliminatinginfectious agents is enhanced by having one or more of the “smart”features operating within the smart light engine system 10.

FIG. 11-11D best show the component parts and operation of the fiberoptic disposable 96. FIG. 11 is an exploded view of the fiber opticdisposable 96 of FIG. 9 showing various component parts and the relativedisposition of each component part. The proximal end 102 comprises abarrel 116 with a female luer adapter 118 that serves as a couplingadapter (in FIG. 9 , a male luer plug 120 plugs the female luer adapter118 for transport and storage), a check valve 122, and a capture ring124. The check valve 122 captures the proximal end of thecollapsible/retractable sleeve 100 and secures it against the insidewall of the barrel 116. The check valve 122 (also depicted in FIG. 11Ain an exploded view) further comprises a check valve body 126, a checkvalve disk 128, a check valve cap 130, and a central bore 132 alignedthrough each component of the check valve 120 and is the bore throughwhich the optical fiber 98 passes when advanced. As the optical fiber 98is advanced the collapsible/retractable sleeve 100 is collapsed to nestwithin the barrel 116 placing the fiber optic disposable 96 into itsfiber-advanced, collapsed mode. The check valve 122 permits the sterileenvironment inside the collapsible/retractable sleeve 100 between theproximal end 102 and the distal end 104 to move/escape through the checkvalve 122 as the fiber optic disposable 96 is advanced from itsretracted mode to its collapsed mode (which also is a fiber-advancedmode).

The distal end 104 (also shown in FIGS. 11B-11D) further comprises abarrel plug 134 with a barrel plug cap 136, a ferrule 138, a magneticwasher 140, a ferrule cap 142 and an optical fiber receiving bore 144centrally aligned through each component of the barrel plug 134. Theferrule cap surrounds and protects the ferrule 138 during transport andstorage. The barrel plug 134 seats into and seals the barrel 116capturing the collapsible/retractable sleeve 100 snugly within theinterior of the barrel 116. The proximal end of thecollapsible/retractable sleeve 100 is secured in air-tight fashion aboutthe barrel plug cap 136 to maintain the sterility of the interior of thecollapsible/retractable sleeve 100. The optical fiber 98 has areinforced end 146 that is disposed within and through the optical fiberreceiving bore 144 for aligned connection to the distal connector 60 ofthe umbilical light transmission cable 44. FIG. 11B is a perspectiveview of the fully assembled distal end 104 ready for connection to thedistal connector 60 of the umbilical light transmission cable 44 whileFIG. 11C is an exploded perspective view of the distal end 104 detachedfrom the collapsible/retractable sleeve 100 and the ferrule 138 andmagnetic washer 140 exploded from the barrel plug 134. FIG. 11D is aperspective end view of the ferrule cap 142 engaged to surround andprotect the ferrule 138 during transport and storage.

FIG. 12 is a plan view of an exemplary fiber optic introducer 148 as itwould appear during transport or storage with protective caps sealingeach accessible port. The fiber optic introducer 148 shown isparticularly suitable for use with a dialysis catheter having anextension set disposed between the dialysis catheter and a dialysatesource or waste receptacle. As depicted, the exemplary fiber opticintroducer 148 is a Y-connector having a main line 150 between an entryport 152 and an exit port 154 and a branching line 156 between the mainline 150 and a side port 158. Also depicted are various accessories forthe fiber optic introducer 148; namely, a clamp 160 for selectivelyclosing and opening the branching line 156 and differing types ofsealing caps 162 for sealing the entry port 152, exit port 154, and sideport 158. Generally, Y-connectors are well known, although the depictedexemplary fiber optic introducer 148 is particularly suitable for usewith a dialysis catheter. Consequently, the types of connections at theports may differ from other Y-connectors to accommodate connections toan extension set, a dialysis catheter, and umbilical light transmissioncable 44 (as shown in FIG. 13 ).

Although the depicted exemplary fiber optic introducer 148 isparticularly suitable for use with a dialysis catheter, it should beunderstood the scope of the invention disclosed herein is not to belimited to use with a dialysis catheter. Rather, use of the inventionwith a dialysis catheter is intended as an example of one of many usescontemplated and applicant has selected to describe use with a dialysiscatheter as representative and informative regarding other usescontemplated. Those skilled in the art, enabled by this disclosure,could readily modify the configuration of the exemplary fiber opticintroducer 148 to accommodate different uses of the invention withoutdeparting from the intended scope and spirit of the invention.

FIG. 13 depicts a representative use of the fiber optic introducer 148in a representative peritoneal dialysis (PD) catheter environment. Thefiber optic introducer 148 is shown connected to an extension set 164, asingle-cuff PD catheter 166 and an umbilical light transmission cable 44via a fully collapsed fiber optic disposable 96 (i.e., in itsfiber-advanced, collapsed mode) with the fiber optic 98 advanced throughthe fiber optic introducer 148 into the tubular extension set 164. Asdepicted, the fiber optic introducer 148 facilitates the flow of fluidssuch as fresh dialysate and/or waste dialysate and the delivery of EMRfor radial emission. With the depicted configuration, the optical fiber98 has been advanced into and through the main line 150 of the fiberoptic introducer 148 and into the extension set 164 (a tubular extensionof the PD catheter 166 that is located outside of a patient’s body) byadvancing the optical fiber 98 and collapsing thecollapsible/retractable sleeve 100 (not shown) into the barrel 116 ofthe fiber optic disposable 96 and into the fiber-advanced, collapsedmode. As extended, the optical fiber 98 is positioned to deliver andemit radially sterilizing EMR into, on, and around the fiber opticintroducer 148 (having a tubular structure portion) and the extensionset 164 (as depicted in an exemplary fashion by rays extending radiallytherefrom). In this fashion, the fiber optic introducer 148 and theextension set 164 may be sterilized before dialysis treatment isinitiated to prevent infection agents from populating. However, ifdesired, the radial emission of sterilizing EMR may also be deliveredand emitted when dialysate (fresh or waste) is present within the fiberoptic introducer 148 and/or the extension set 164.

The collection of FIGS. 14A-C is a series of perspective views of anexemplary PD catheter 166 illustrating exemplary radial EMR emissions.Although both peritoneal dialysis and hemodialysis require access to apatient’s body via some type of dialysis access (in this case a PDcatheter 166), peritoneal dialysis has several advantages overhemodialysis including quality of life due to its ability to providebetter patient mobility and independence, the simplicity of the dialysisaccess, the simplicity of use, as well as the clinical advantages ofmaintaining residual renal function and lower mortality in the firstyears after starting peritoneal dialysis. A disadvantage of peritonealdialysis is the risk of peritonitis. Peritonitis is often the result ofcontamination with skin bacteria, but it may also be due to theretrograde migration of microbes on the catheter. Systemic orintra-peritoneal antibiotics may be administered, and the exchangevolumes may be decreased. Although PD catheter-related peritonitis mayresolve with proper antibiotic therapy, delivery of EMR using bothcontrolled relative intensity and treatment region specific dosingutilized alternatively, simultaneously, or alternately may prove to bemore effective in preventing and assisting in the treatment ofperitonitis. If the infection persists, catheter removal and use ofhemodialysis for 4-6 weeks may be required to resolve the peritonitis.Because there is a strong association between exit-site infections andsubsequent peritonitis, early, preventative delivery followed bymaintenance delivery of EMR as described herein may prevent, inhibit, oreliminate exit-site infections that may lead to peritonitis.

Peritoneal refers to the lining that surrounds the organs in a patient’sabdomen. That lining is called the peritoneal membrane. It forms a spacecalled the peritoneal cavity that can hold fluid. With peritonealdialysis, a long-term indwelling or permanent catheter is insertedthrough the lining into the space around the patient’s organs. Dialysissolution (also known as dialysate) is delivered through the catheterinto that space. The peritoneal lining contains many blood vessels. Thedialysate draws extra fluid, chemicals, waste out of those blood vesselsand through the lining. The lining acts as a filter. The dialysate isleft in place for several hours while dialysis occurs. Then the old,waste-laden solution (also known as waste dialysate) is allowed to drainout through the catheter for disposal. Fresh, clean solution (dialysate)is immediately delivered in, filling in the space again. This process ofexchanging waste dialysate with fresh dialysate is called an exchange.

The two-cuff PD catheter 166 shown in FIGS. 14A-C comprises a connectorhub 168, a peritoneal cuff 170, a subcutaneous cuff 172, and a coiledTenckhoff 174. This exemplary PD catheter 166 has three regions, anexternal region 176, a tunneled region 178 (extending from the exit sitelocation 180 to just inside the peritoneal membrane), and anintra-peritoneal region 182. When the two-cuff PD catheter 166 is placedwithin the patient, the external region 1768 protrudes from the body ofthe patient at the exit site location 180 and is visible, the tunneledregion 178 is tunneled through the subcutaneous tissue, the rectusmuscle, and the peritoneal membrane, while the intra-peritoneal region182 is disposed within the peritoneal cavity. It should be understoodthe exit site is the region where external region 176 protrudes from thepatient’s body and is depicted as an exit site location 180 on the PDcatheter 166 (in FIGS. 14A-C) when the PD catheter 166 is positioned fordialysis. An optical fiber 98 is shown as disposed within the lumen ofthe PD dialysis catheter 166 extending just beyond the peritoneal cuff170.

FIG. 14A depicts the exemplary two-cuff PD catheter 166 showing anexemplary radial emission of EMR extending from and including theconnector hub 168 to a point proximate to and downstream from theperitoneal cuff 170 inside of the peritoneal membrane (including radialEMR emission within the external region 176, and the tunneled region178).

FIG. 14B depicts the exemplary two-cuff PD catheter 166 showing theradial emission of EMR between the exit site location 180 upstream ofthe subcutaneous cuff 172 and a point downstream of the peritoneal cuff170 inside of the peritoneal membrane (radial EMR emission within thetunneled region 178).

FIG. 14C depicts the exemplary two-cuff PD catheter 166 showing theradial emission of EMR between the connector hub 168 and a pointdownstream of the peritoneal cuff 170 and extending into a peritonealdialysis solution region 184 during dialysis (including radial EMRemission within the external region 176, the tunneled region 178, andthe intra-peritoneal region 182).

FIG. 15A depicts an exemplary extended PD catheter assembly 186comprising a Y-port adapter 188, extension line tubing 190 (an exemplarytubular structure), and a connecting luer 192. Radial EMR emission isshown only in a Y-site/transfer region 194. In this configuration, theY-port adapter 188 differs from the fiber optic introducer 148 in thatthe optical fiber 98 may be introduced into and through the branchingline 156, into and through the extension line tubing 190, and into thePD catheter 166. The extent to which the optical fiber 98 extends intothe extended PD catheter assembly 186 is determined by the length of theoptical fiber 98. For example, for the configuration and the radialemission shown in FIG. 15A, the optical fiber 98 need only have anoverall length that extends just beyond the Y-port adapter 188 whenfully inserted.

FIG. 15B depicts the exemplary extended PD catheter assembly 186 of FIG.15A showing radial EMR emission only exterior to the patient’s bodywithin the Y-site/transfer region 194, within an extension set region196, within a connection hub region 198, and within the external region176. Additionally, for the configuration and the radial emission shownin FIG. 15B, the optical fiber 98 need only have an overall length thatextends just short of the exit site location 180 when fully inserted.

FIG. 15C depicts the exemplary extended PD catheter assembly 186 of FIG.15A showing radial EMR emission along the full length of the at distinctregions: namely, within the Y-site/transfer region 194, the connectionhub region 198, the tunneled region 178, and the intra-peritoneal region182. This exemplary embodiment provides radial EMR emission in exteriorregions susceptible to contamination-caused infections; namely, theY-site/transfer region 194 and the connection hub region 198simultaneously with radial EMR emission inside the patient’s body. Forthe configuration and the radial emission shown in FIG. 15B, the opticalfiber 98 has an overall length that extends through the extended PDcatheter assembly 186 into the coiled Tenckhoff 174.

Radial EMR emission at distinct regions may be accomplished by emittingthe EMR from multiple distinct radial emission portions along theoptical fiber 98 as disclosed and described in the Parent Application.

Similarly, FIG. 15D depicts the exemplary extended PD catheter assembly186 of FIG. 15A, however, this configuration shows radial EMR emissionalong the full length of the extended PD catheter assembly 186 to apoint within the coiled Tenckhoff 174. This exemplary embodimentdemonstrates that radial EMR emission may be delivered over the fullextent of the extended PD catheter assembly 186, including exteriorregions susceptible to contamination-caused infections and regionswithin the patient’s body. In combination with the other figures, FIG.15D demonstrates that any combination of regions along the length of theextended PD catheter assembly 186 may have radially emitted EMR on oroff as desired to employ controlled relative intensity and/or treatmentregion specific application of the therapeutic doses.

Also, by extending the optical fiber 98 into the coiled Tenckhoff 174 asshown in FIG. 15D, the optical fiber 98 may prevent occlusion of holes200 and/or tissue adhesion to the coiled Tenckhoff 174. To avoiduncoiling the coiled Tenckhoff 174, a smaller diameter optical fiber 98fiber may be required (at least in the region of the optical fiber 98that extends into the coiled Tenckhoff 174).

FIG. 16A is a schematic view of another exemplary embodiment of a PDcatheter 166 as inserted into peritoneal dialysis solution 202 within afemale patient’s body 204. This exemplary embodiment demonstrates asingle-cuff PD catheter 166 connected to a light engine box 12 via anumbilical light transmission cable 44 and a Y-port adapter 188. Noradial EMR emission rays are shown because the light engine box 12 isturned off.

FIG. 16B depicts the exemplary single-cuff PD catheter 166 as insertedwithin a female patient’s body 204. This exemplary embodiment shows thatthe light engine box 12 has been turned on to provide radial EMRemission downstream of the light engine box 12 and the attachedumbilical light transmission cable 44. For illustration purposes only(this configuration would never be used knowingly during actualoperation), the umbilical light transmission cable 44 is detached andwithdrawn slightly from its attachment to the Y-port adapter 188 toreveal the optical fiber 98 as introduced into the branching line 156and extending downstream within the lumen of the PD catheter 166 intothe peritoneal dialysis solution region 184. As depicted, radial EMRemission is provided through the Y-site/transfer region 194, theexterior region 176 upstream of the subcutaneous cuff 172, within thetunneled region 178, and into the peritoneal dialysis solution 202within the peritoneal dialysis region 184. This configurationdemonstrates that the radial EMR emission may be supplied external tothe patient’s body 204 simultaneously with supplying radial EMR emissionat a distinct location within the patient’s body, if desired for aparticular treatment need.

FIG. 17 is a schematic view of an exemplary embodiment of a peritonealdialysis system 206 showing dialysate supply and return bags. Theschematic depiction is a basic representation of peritoneal dialysissystems 206. The use of this basic representation is not intended to belimiting of the scope of the present invention; rather, this disclosurecontemplates and considers the use of the disclosed invention withindifferent or more sophisticated peritoneal dialysis systems, known andyet to be developed, to be within the scope of the present invention.For example, there are two kinds of peritoneal dialysis, ContinuousAmbulatory Peritoneal Dialysis (known as CAPD) which is the kind ofperitoneal dialysis depicted in FIG. 17 and Automated PeritonealDialysis (known as APD). CAPD is “continuous,” machine-free and donewhile the patient goes about their normal activities. The exchange ofdialysis fluids (dialysate and waste dialysate) is done manually by theuser/patient and fluid flow is typically gravity driven. APD differsfrom CAPD in that a machine (cycler) delivers and then drains thecleansing fluid automatically for the patient. The treatment usually isdone at night while the patient sleeps. Enabled by this disclosure,those skilled in the art will understand where, when, and how thedelivery of EMR as disclosed herein may be used in different (such asAPD systems) or more sophisticated peritoneal dialysis systems, knownand yet to be developed.

The basic peritoneal dialysis system 206 (depicted in FIG. 17 )comprises dialysis access via a PD catheter 166, a fluid extension line208, a dialysate exchange switch 210, a dialysate supply bag 212, and awaste dialysate retrieval bag 214. As described with reference to FIGS.14A-C, 15A-D, and 16A-B, the catheter (also referred to a PD catheter166) has an external region 176, a tunneled region 178, anintra-peritoneal region 182, a coupling end and a distal end. Thecoupling end of the PD catheter 166 is connected to the fluid extensionline 208 via an extension connector 216. The fluid extension line 208 isconnected to the dialysate exchange switch 210. The dialysate exchangeswitch 210 has an extension line portal 218, a dialysate inlet 220, awaste dialysate outlet 222 and an exchange selector 224 for selectingfluid flow paths. The dialysate supply bag 212 contains dialysate 202(also referred to as peritoneal dialysis solution 202) and is connectedto the dialysate exchange switch 210 via a feed line 226 and thedialysate inlet 220, establishing a dialysate flow path (when theexchange selector 224 is moved to select dialysate flow) from thedialysate supply bag 212 into the feed line 226, through the dialysateexchange switch 210, into and through the fluid extension line 208, tothe PD catheter 166 for delivery into the patient’s body 204.

With peritoneal dialysis, a long-term, indwelling, or permanent PDcatheter 166 is or may have already been inserted through the peritoneallining into the abdominal space 184 (sometimes referred to as theperitoneal dialysis solution region 184) around the patient’s organs.Dialysis solution 202 (also referred to as dialysate 202) is deliveredin the direction of Arrow A from the dialysate supply bag 212 throughthe PD catheter 166 into that abdominal space 184. The peritoneal liningcontains many blood vessels. The dialysate 202 draws extra fluid,chemicals, waste out of those blood vessels and through the peritoneallining. Hence, the peritoneal lining acts as a filter. The dialysate 202is left in place for a several hours while dialysis occurs. Then theold, waste-laden dialysis solution 228 (sometimes referred to as wastedialysate 228) is allowed to drain out through the PD catheter 166 fordisposal. Fresh, clean solution (dialysate) 202 is immediately deliveredin, filling in the abdominal space 184 again. This process of exchangingold (waste dialysate) solution 228 with new dialysate 202 is called anexchange.

The peritoneal dialysis system 206 has been enhanced by adding a lightengine system 10 comprising a light engine box 12 and an optical fiber98. This enhancement of the peritoneal dialysis system 206 may be partof a kit that includes the peritoneal dialysis system 206 and the lightengine system 10 (whether the light engine system 10 is permanentlyconnected to the peritoneal dialysis system 206 or removably insertableinto the peritoneal dialysis system 206). Alternatively, the lightengine system 10 may be retrofitted with an existing peritoneal dialysissystem 206. As depicted, the optical fiber 98 of the light engine system10 is introduced into the external region 176 of the PD catheter 166through an introducing adapter 230 that facilitates the passage of theoptical fiber 98 into the lumen of the PD catheter 166 without impairingthe free flow of fluid through the PD catheter 166.

For illustration purposes only (this configuration would never be usedknowingly during actual operation), the umbilical light transmissioncable 44 is detached and withdrawn slightly from its attachment to theintroducing adapter 230 to reveal the optical fiber 98 as introducedinto the lumen of the PD catheter 166. When the umbilical lighttransmission cable 44 is connected to the light engine box 12 and theoptical fiber 98 is disposed within the lumen of the PD catheter 166(the connection between the umbilical light transmission cable 44 andthe optical fiber 98 has been omitted so not to obscure other featuresdepicted), the therapeutic, non-ultraviolet EMR may be delivered wheredesired. The depiction in FIG. 17 shows radial delivery of EMR withinthe external region 176 and the tunneled region 178 of the PD catheter166.

Of course, it should be understood the invention of this disclosure asdescribed herein may provide radial emission of the EMR light in thelocations, at the intensities, and with the controlled relativeintensity and/or treatment region specific application of therapeuticdoses of the EMR light discussed above.

As depicted in FIG. 17 , the dialysate exchange switch 210 is set forthe waste cycle where waste dialysate 228 is withdrawn from theabdominal space 184 in the direction of Arrows B, through a dialysisaccess such as the PD catheter 166 and the extension connector 216, intothe fluid extension line 208, into the dialysate exchange switch 210 viathe extension line portal 218, and out through the waste dialysateoutlet 222 into a drainage line 232 and then the waste dialysateretrieval bag 214 for disposal.

FIG. 18 is a schematic depiction of another exemplary embodiment of aportion of the peritoneal dialysis system 206 (omitting the dialysatesupply bag 212 and the waste dialysate retrieval bag 214 showing theemission of EMR light at a treatment location within the fluid extensionline 208 (sometimes called a PD extension catheter) and into thedialysate exchange switch 210 in the vicinity of the extension lineportal 218. This exemplary embodiment utilizes the light engine system10 with light engine box 12, umbilical light transmission cable 44,fiber optic disposable 96, fiber optic introducer 148 for delivering EMRto the fluid extension line 208 and the dialysate exchange switch 210,where the PD catheter 166 having a coiled Tenckhoff 174 is alsoconnected to the fiber optic introducer 148 via branching line 156. Thisdepiction illustrates the versatility of the light engine system 10 inthat it may also be used to sterilize the fluid extension line 208 andthe dialysate exchange switch 210 independent of delivering EMR to thePD catheter 166 by inserting the optical fiber 98 into the fluidextension line 208. With this configuration, the therapeutic EMR may bedelivered before dialysis begins, during dialysis, during wastedialysate 228 retrieval, and/or after the dialysis treatment iscomplete.

FIG. 19 is a schematic depiction of another exemplary embodiment of aportion of the peritoneal dialysis system 206 (omitting the dialysatesupply bag 206 and the waste dialysate retrieval bag 214) showing dualEMR delivery from the light engine box 12. With this embodiment, twooptical fibers 98 extend from the distal connector 60 of the umbilicallight transmission cable 44 to depict schematically that two laserassemblies 34 within the light engine box 12 supply two distinct EMRsources may connect with a dual receiver adapter 234 that receives anddirects the EMR into one optical fiber 98 inserted into the fluidextension line 208, and the other optical element 18 inserted into thePD catheter 166. The EMR light delivered may be the same for eachoptical fiber 98. In other instances, a receiver adapter 234 may be usedthat split a single EMR source into two separate optical fibers 98inside the receiver adapter 234. Also, when two or more EMR sourcesdeliver EMR respective optical fibers 98, the EMR delivered may differfor each optical fiber 98. For example, EMR may be deliveredalternatively, alternatingly, or simultaneously, and with differingfrequencies, intensities, and dosages to provide controlled relativeintensity and/or treatment region specific application of therapeuticdoses of the EMR where and when desired within the peritoneal dialysissystem 206.

FIG. 19 shows an exemplary configuration conducive to simultaneous EMRdelivery into the fluid extension line 208 and the PD catheter 166.Also, depicted is a line clamp 236 used to occlude the fluid extensionline 208 so that fluid (waste dialysate 228, as depicted) will not drainthrough the fluid extension line 208 into the waste dialysate retrievalbag 214 during the dialysis process once the peritoneal dialysissolution region 184 is filled and before the waste cycle. As depicted,the portion of the fluid extension line 208 between the line clamp 236and the dialysate exchange switch 210 is being sterilized by the EMRradially emitting from the optical fiber 98.

Still another exemplary embodiment of a peritoneal dialysis system 206is depicted schematically in FIG. 20 showing a dual EMR delivery usingtwo light engine systems 10. With this embodiment, two optical fibers 98extend from separate light engine boxes 12 and into a dual introducingmulti-direction adapter 238, one optical fiber 98 inserted into thefluid extension line 208, and the other optical fiber 98 inserted intothe PD catheter 166. The EMR delivered may be the same for each opticalfiber 98. However, separate light line boxes 12 make it possible to haveeach optical fiber 98 operate totally independent of the other opticalfiber 98. Hence, the EMR delivered may be provided alternatively,alternatingly, or simultaneously, and with differing frequencies,intensities, and dosages so to provide controlled relative intensityand/or treatment region specific application of therapeutic doses of theEMR where and when desired within the peritoneal dialysis system 206.Specifically, FIG. 20 shows simultaneous EMR delivery into the fluidextension line 208 and the PD catheter 166; however, each may beemitting EMR with different frequencies, intensities, and dosages.

Yet another exemplary embodiment of a peritoneal dialysis system 206 isdepicted in FIG. 21 and shows dual EMR delivery (like the configurationin FIG. 20 ) using a single light engine box 12. With this embodiment,two umbilical light transmission cables 44 extend from the light enginebox 12 (each connected to a different laser assembly 34, not shown) andeach of the umbilical light transmission cables is connected to the dualintroducing multi-direction adapter 238, one optical fiber 98 beinginserted into the fluid extension line 208, and the other optical fiber98 being inserted into the PD catheter 166. Again, the EMR delivered maybe the same for each optical fiber 98. In this instance, however, thesingle light engine box 12 may deliver differing EMR to each opticalfiber 98, making it possible to have each optical fiber 98 operateindependent of each other. Again, the EMR delivered may be providedalternatively, alternatingly, or simultaneously, and with differingfrequencies, intensities, and dosages so to provide controlled relativeintensity and/or treatment region specific application of therapeuticdoses of the EMR where and when desired within the peritoneal dialysissystem 206. Specifically, FIG. 21 also shows simultaneous EMR deliveryinto the fluid extension line 208 and the PD catheter 166; however, eachmay be emitting EMR of different frequencies, intensities, and dosages.

Hemodialysis is a treatment that removes wastes and extra fluid from apatient’s blood when the patient’s own kidneys have failed. Beforehemodialysis can be done, a connection must be made to the blood insidethe patient’s blood vessels. One of a several different types ofdialysis access 240, such as a vascular access, reaches a patient’sblood for hemodialysis. The dialysis access 240 allows the patient’sblood to travel through soft tubes (such as extension tubing, catheters,and like tubular structures) to the dialysis machine where it is cleanedas it passes through a special filter acting as an artificial kidney,called a dialyzer. Generally, there are three principal different typesof dialysis access 240 used for hemodialysis. They are called a fistula,a graft, and a catheter (or hemodialysis catheter). There are pros andcons of each one. Typically, a special surgeon with hemodialysis accessexperience will determine, recommend, and/or select which type ofdialysis access 240 will be appropriate for each patient.

To get blood into the dialyzer, a dialysis access 240, or entrance, intothe patient’s blood vessels must be made. Typically, this is done withminor surgery, usually to an arm or leg or elsewhere depending on wherethe dialysis access 240 is most appropriate for the patient 204.

For hemodialysis, catheters are generally used as a temporary dialysisaccess 240, in case of an emergency need for dialysis or while waitingfor dialysis access surgery to create either a fistula or a graft andfor the fistula or graft to mature, but sometimes catheters providepermanent dialysis access 240. Hemodialysis catheters are soft tubes(i.e., soft tubular structures) placed into a large vein in the neck orsometimes elsewhere such as in the leg.

An arteriovenous fistula, a dialysis access 240 made by joining anartery and a vein in the patient’s arm (or leg), is generally consideredadvantageous because it lasts longer and has fewer problems such asinfections and clotting. An arteriovenous fistula should be placedseveral months before it is needed to start dialysis. This allows thefistula enough time to be ready for when treatment is needed and starts.A fistula usually takes one to four months to “mature” or enlarge beforeit can be used. However, some patients may not be able to receive afistula because their blood vessels are not strong enough.

An arteriovenous graft is a dialysis access 240 made by joining anartery to a closely proximate vein. Minor surgery is done using anartificial tube between the vein and the nearby artery. An arteriovenousgraft is usually put inside the bend of a patient’s arm or in theirupper arm. Sometimes, it may be placed in a patient’s leg or chest wall.The arteriovenous graft generally needs to be in place at least twoweeks after surgery before it can be used. Each of these dialysis access240 options are susceptible to infectious agents.

FIG. 22 is a schematic view of a representative exemplary embodiment ofa hemodialysis system 300 depicting a hemodialysis unit 302 shown inphantom lines, components of the hemodialysis system 300 pertinent tothe invention of this disclosure, and an inset area enlarged as FIG.22A.

The components of the hemodialysis system 300 pertinent to the inventionof this disclosure, include but are not limited to a dialysis access240, a dialyzer 304, a blood pump 306, a dialysate reservoir 308, awaste dialysate reservoir 310, a saline bag 312, a heparin pump 314, anair trap/air detector 316, an arterial-pressure monitor 318, avenous-pressure monitor 320, an inflow-pressure monitor 321, an inboundblood flow tubing 322 (another exemplary tubular structure), and anoutbound blood flow tubing 324 (yet another tubular structure). Some ormost of these components may be enclosed within the hemodialysis unit302. However, as depicted in FIG. 22 , the dialysate reservoir 308,waste dialysate reservoir 310, and saline bag 312 are usually externalto the hemodialysis unit and the dialysis access 240, being an accessinto the patient’s body 204, is always outside the hemodialysis unit302,

FIG. 22A is an enlargement of the inset area identified in FIG. 22showing an exemplary dialysis access 240, a representative fistulaaccess, into the patient’s 204 arm, showing an outbound venous line 326and an inbound arterial line 328.

Blood from the patient 204 is drawn into the outbound venous line 326and the outbound blood flow tubing 324 in the direction of Flow ArrowsC, and is pumped into the dialyzer 304, where the blood is cleaned. Adialysate solution is drawn from the dialysate reservoir 308 into thedialyzer 304, in the direction of Inflow Arrow D, via a feed line 332 tointeract with the venous-drawn blood, to filter it and remove waste andextra fluid from the blood, thereby serving as an artificial kidney. Thecleaned, fresh blood exits the dialyzer 304 and flows (again in thedirection of Flow Arrows C) into the inbound blood flow tubing 322 andthen the inbound arterial line 328 to be circulated within the patient204. The dialysate solution exiting the dialyzer 304 is waste dialysate228 that carries out the waste, other impurities, and the extra fluid asit drains through the drainage line 334, in the direction of DrainageArrow E, into the waste dialysate reservoir 310 for disposal.

As the filtered, fresh blood circulates through the patient’s body 204,it gathers and collects waste, other impurities, and extra fluid beforeit again is drawn from the patient 204 into the outbound venous line 326and the outbound blood flow tubing 324 in the direction of Flow Arrows Cand is pumped into the dialyzer 304 to be cleaned. The cycle ofcirculation through the patient’s body 204 and the hemodialysis unit 302continues to repeat until dialysis is complete.

During dialysis, the blood pump 306 regulates the flow of the bloodthrough the hemodialysis unit. The heparin pump 314 infuses heparin intothe blood to prevent the blood from clotting. A saline solution thatflows from the saline bag 312 through a saline line 330 into theoutbound blood flow tubing 324 (or, in some instances, directly into thedialyzer 304) is vital to the dialysis process. It is the salinesolution in the dialyzer 304 that serves as the agent used to cleansethe venous-drawn blood within the dialyzer 304. The venous-pressuremonitor 320 monitors the pressure within the outbound blood flow tubing324 so that pressure may be maintained in an operable range.Additionally, the inflow-pressure monitor 321 monitors pressure at alocation downstream of the blood pump 306 and upstream of the dialyzerso that the blood entering the dialyzer is within a proper operatingrange for the dialyzer 304. Similarly, the arterial-pressure monitor 318monitors the pressure within the inbound blood flow tubing 322 so thatpressure may be maintained in an operable range. The air trap/airdetector 316 detects and traps undesirable air bubbles within theinbound blood flow tubing 322 before such air bubbles enter thepatient’s body 204 and cause serious consequences to the patient 204.

During preparations for dialysis and the actual hemodialysis process,there are occasions when either the patient 204 or a person assistingthe patient 204 may access or handle various connections, materials, orcomponent parts involved in the dialysis. Such accessing or handling mayintroduce or increase the possibility of infectious agents contaminatingthe hemodialysis equipment or process. Certain components can beidentified as being particularly susceptible to such contamination.Consequently, being able to sterilize such components and/or to reduceor eliminate such infectious agents could reduce or eliminate one of themost serious concerns about having to undergo dialysis.

FIG. 22 depicts several representative locations where the delivery oftherapeutic EMR could be instrumental in preventing, reducing, oreliminating infections that are known to be pernicious to undergoingdialysis. Four separate light engine systems 10 are depicted in FIG. 22as representative locations for delivering therapeutic EMR. Althougheach of the locations depicted are shown as external to the hemodialysisunit 302 and as such may be retrofitted into an existing hemodialysissystem 300, it should be understood one or more of the light enginesystems 10 may be disposed permanently within the hemodialysis unit 302.Also, although FIG. 22 depicts four separate light engine systems 10having four separate light engine boxes 12, it should be understood one,more than one, or all EMR delivery locations may be operated by a singlelight engine box 12.

As depicted, one light engine system 10 is placed to deliver EMR tosterilize the saline solution and/or the saline line 330 or inactivateinfectious agents in the saline solution and/or on or in the saline line330. This light engine system 10 comprises a light engine box 12 thatprovides the EMR at the desired intensity(ies), an umbilical lighttransmission cable 44 that receives and conveys the EMR from the lightengine box 12 through an introducing adapter 230 into the saline line330.

Another light engine system 10 is placed to deliver EMR to sterilize thedialysate solution and/or the feed line 332 or inactivate infectiousagents in the dialysate solution and/or on or in the feed line 332. Thislight engine system 10 comprises a light engine box 12 that provides theEMR at the desired intensity(ies), an umbilical light transmission cable44 that receives and conveys the EMR from the light engine box 12through an introducing adapter 230 into the feed line 332.

The other two light engine systems 10 are used to deliver EMR to therepresentative dialysis access 240 are best depicted in FIG. 22A. Therepresentative dialysis access 240 depicted is a fistula comprising anarterial access 328 and a venous access 326. The arterial access 328 andthe venous access 326 comprises access needles (not shown) and theinbound blood flow tubing 322 and outbound blood flow tubing 324,respectively. One of the light engine systems 10 is placed to deliverEMR to sterilize blood and/or the outbound blood flow tubing 324 orinactivate infectious agents in the blood and/or on or in the outboundblood flow tubing 324. The other light engine system 10 is placed todeliver EMR to sterilize blood and/or the inbound blood flow tubing 322or inactivate infectious agents in the blood and/or on or in the inboundblood flow tubing 322. Each light engine system 10 comprises a lightengine box 12 that provides the EMR at the desired intensity(ies), anumbilical light transmission cable 44 that receives and conveys the EMRfrom the light engine box 12 through an introducing adapter 230 into theoutbound blood flow tubing 324 and the inbound blood flow tubing 322,respectively.

For exemplary methods or processes of the invention, the sequence and/orarrangement of steps described herein are illustrative and notrestrictive. Accordingly, it should be understood although steps ofvarious processes or methods may be shown and described as being in asequence or temporal arrangement, the steps of any such processes ormethods are not limited to being carried out in any one sequence orarrangement, absent an indication otherwise. Indeed, the steps in suchprocesses or methods generally may be carried out in various sequencesand arrangements while still falling within the scope of the presentinvention.

Additionally, any references to advantages, benefits, unexpectedresults, or operability of the present invention are not intended as anaffirmation that the invention has been previously reduced to practiceor that any testing has been performed. Likewise, unless statedotherwise, use of verbs in the past tense (present perfect or preterit)is not intended to indicate or imply that the invention has beenpreviously reduced to practice or that any testing has been performed.

Exemplary embodiments of the present invention are described above. Noelement, act, or instruction used in this description should beconstrued as important, necessary, critical, or essential to theinvention unless explicitly described as such. Although severalexemplary embodiments have been described in detail herein, thoseskilled in the art will readily appreciate that many modifications arepossible in these exemplary embodiments without materially departingfrom the novel teachings and advantages of this invention. For example,the delivery of EMR via an optical element comprising a fiber optic, asdisclosed, and claimed herein, is not limited to delivery of EMR in, on,and around catheters only, but may also deliver EMR in, on, and aroundother tubular structures. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe appended claims.

In the claims, any means-plus-function clauses are intended to cover thestructures described herein as performing the recited function and notonly structural equivalents, but also equivalent structures. Thus,although a nail and a screw may not be structural equivalents in that anail employs a cylindrical surface to secure wooden parts together,whereas a screw employs a helical surface, in the environment offastening wooden parts, a nail and a screw may be equivalent structures.Unless the exact language “means for” (performing a particular functionor step) is recited in the claims, a construction under Section 112, 6thparagraph is not intended. Additionally, it is not intended that thescope of patent protection afforded the present invention be defined byreading into any claim a limitation found herein that does notexplicitly appear in the claim itself.

While specific embodiments and applications of the present inventionhave been illustrated and described, it is to be understood that theinvention is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent invention disclosed herein without departing from the spirit andscope of the invention.

What is claimed is:
 1. An electromagnetic radiation (EMR) deliverysystem for delivering EMR at wavelengths, intensities, exposures, anddurations to locations inside and/or outside a patient’s body in, on,and surrounding a tubular structure having a lumen and comprising atube, a catheter, and/or a catheter extension, to prevent, reduce,and/or eliminate infectious agents in, on, or surrounding the tubularstructure and/or to enhance healthy cell growth, the EMR delivery systembeing connected to a power supply and comprising: at least one lightengine box for connection to the power supply and for generatingtherapeutic EMR, each light engine box comprising: at least one laserassembly disposed within the light engine box that receives power fromthe power supply and generates a non-ultraviolet, therapeutic EMR havingan intensity comprising a range of radiant exposures from 0.1 J/cm² to 5kJ/cm², and a range of powers from 0.005 mW to 5 W, and a power densityrange from 1 mW/cm² and 2 W/cm², such intensity being sufficient toproduce a therapeutic effect of at least one of inactivating one or moreinfectious agents and enhancing healthy cell growth; and at least onecable adapter, each cable adapter being connected to one laser assembly;a light transmission cable having a proximate end and a distal end, theproximate end being connected with the cable adapter, the cable adapterfor receiving therapeutic EMR from the laser assembly and facilitatingthe propagation of the therapeutic EMR from the laser assembly to andthrough the light transmission cable to the distal end of the lighttransmission cable for delivery to the tubular structure; and an opticalelement connected to the light transmission cable, the optical elementcomprising a fiber optic for disposition within the lumen of the tubularstructure, the fiber optic being conducive to the axial propagation ofthe therapeutic EMR relative to the tubular structure, the fiber opticfurther comprises at least one radial emission portion disposed betweena coupling end of the fiber optic and a distal end of the fiber optic.2. The EMR delivery system of claim 1 wherein the light engine box is asmart light engine box and further comprises a central processing unit(CPU) that controls features provided by the smart light engine box, theCPU being connected to the power supply and being at least one ofpre-programmed and programmable.
 3. The EMR delivery system of claim 2wherein the smart light engine box further comprises a test module and asubminiature version A (SMA) optical fiber connector, the SMA opticalfiber connector facilitates the connection of the test module to thedistal end of the light transmission cable such that therapeutic EMR isdelivered to the test module from the distal end of the lighttransmission cable and the delivered therapeutic EMR is tested by thetest module, the test module sends test results to the CPU to beanalyzed against predetermined EMR parameters and the CPU determines thehealth of the laser assembly and any degradation in the therapeutic EMRdelivered to the test module.
 4. The EMR delivery system of claim 3wherein the smart light engine box further comprises an alarm alert thatactivates when the CPU indicates to the alarm alert that the therapeuticEMR fails to meet the predetermined therapeutic EMR parameters,indicating that one of the health of the laser assembly is compromisedor the light transmission cable has degraded and requires replacement.5. The EMR delivery system of claim 2 wherein the smart light engine boxfurther comprises a treatment actuator to initiate a pre-programmeddosing treatment of therapeutic EMR meeting the predeterminedtherapeutic EMR parameters, the treatment actuator being manuallyactivated.
 6. The EMR delivery system of claim 5 wherein the smart lightengine box further comprises an alarm alert that activates when the CPUindicates to the alarm alert that the smart light engine box is in afailure mode, the treatment actuator being manually deactivated when thefailure mode is indicated.
 7. The EMR delivery system of claim 2 whereinthe light transmission cable is an umbilical light transmission cablecomprising at least one transmission wire to facilitate the transmissionof at least one of data and electricity.
 8. The EMR delivery system ofclaim 7 wherein the smart light engine box further comprises an alarmalert that activates when the CPU indicates to the alarm alert that anytransmission within any transmission wire has been disrupted.
 9. The EMRdelivery system of claim 2 wherein the optical element comprises a fiberoptic disposable, the fiber optic disposable has an elongate structure,a retracted mode, and a fiber-advanced mode and comprises the fiberoptic, a proximal end for connection to the distal end of the lighttransmission cable, a distal end for advancing into the tubularstructure, the fiber optic is maintained in a sterile environment whenthe fiber optic disposable is in the retracted mode, when the fiberoptic is advanced into the lumen of the tubular structure the fiberoptic disposable is in the fiber-advanced mode.
 10. The EMR deliverysystem of claim 9 wherein the fiber optic further comprises at least oneradial emission portion disposed between the proximal end of the fiberoptic and the distal end of the fiber optic.
 11. The EMR delivery systemof claim 12 wherein the CPU blocks actuation of the laser assembly whenthe monitoring of usage of the fiber optic disposable is unable tocomplete another treatment before the predetermined useful life of thefiber optic disposable is exhausted.
 12. An EMR delivery system fordelivering EMR at wavelengths, intensities, exposures, and durations tolocations inside and/or outside a patient’s body in, on, and surroundinga tubular structure having a lumen and comprising a tube, a catheter,and/or a catheter extension, to prevent, reduce, and/or eliminateinfectious agents in, on, or surrounding the tubular structure and/or toenhance healthy cell growth, the EMR delivery system being connected toa power supply and comprising: a CPU that controls features provided bythe smart light engine box, the CPU being connected to the power supplyand being at least one of pre-programmed and programmable. at least onesmart light engine box for connection to the power supply and forgenerating therapeutic EMR, each smart light engine box comprising: atleast one laser assembly disposed within the light engine box thatreceives power from the power supply and generates a non-ultraviolet,therapeutic EMR having an intensity comprising a range of radiantexposures from 0.1 J/cm² to 5 kJ/cm², and a range of powers from 0.005mW to 5 W, and a power density range from 1 mW/cm² and 2 W/cm², suchintensity being sufficient to produce a therapeutic effect of at leastone of inactivating one or more infectious agents and enhancing healthycell growth; and at least one cable adapter, each cable adapter beingconnected to one laser assembly via an SMA optical fiber connector; anumbilical light transmission cable having a proximate end and a distalend, the proximate end being connected with the cable adapter, the cableadapter for receiving therapeutic EMR from the laser assembly andfacilitating the propagation of the therapeutic EMR from the laserassembly to and through the umbilical light transmission cable to thedistal end of the umbilical light transmission cable for delivery to thetubular structure, the umbilical light transmission cable comprising atleast one transmission wire to facilitate the transmission of at leastone of data and electricity; and a fiber optic disposable, the fiberoptic disposable having an elongate structure, a retracted mode, and afiber-advanced mode and comprises a fiber optic, a proximal end forconnection with the distal end of the umbilical light transmissioncable, a distal end for advancing into the lumen of the tubularstructure, the fiber optic is maintained in a sterile environment whenthe fiber optic disposable is in the retracted mode, when the fiberoptic is advanced into the lumen of the tubular structure the fiberoptic disposable is in the fiber-advanced mode, the fiber optic beingconducive to the axial propagation of the therapeutic EMR relative tothe tubular structure when in the fiber-advanced mode, the fiber opticfurther comprises at least one radial emission portion disposed betweenproximal end of the fiber optic and a distal end of the fiber optic. 13.The EMR delivery system of claim 12 wherein the smart light engine boxfurther comprises a treatment actuator to initiate a pre-programmeddosing treatment of therapeutic EMR meeting the predeterminedtherapeutic EMR parameters, the treatment actuator being manuallyactivated.
 14. The EMR delivery system of claim 13 wherein the smartlight engine box further comprises an alarm alert that activates whenthe CPU indicates to the alarm alert that the smart light engine box isin a failure mode, the treatment actuator being manually deactivatedwhen the failure mode is indicated.
 15. An EMR delivery fiber opticdisposable for delivering EMR at wavelengths, intensities, exposures,and durations to locations inside and/or outside a patient’s body in,on, and surrounding a tubular structure having a lumen to prevent,reduce, and/or eliminate infectious agents in, on, or surrounding thetubular structure, the EMR delivery fiber optic disposable beingconnected to an EMR delivery system connected to a power supply, the EMRdelivery system comprising a CPU that controls features of the EMRdelivery system, at least one laser assembly that receives power fromthe power supply and generates a non-ultraviolet, therapeutic EMR havingan intensity sufficient to produce a therapeutic effect of at least oneof inactivating one or more infectious agents and enhancing healthy cellgrowth, a light transmission cable having a proximate end and a distalend, the proximate end being connected the laser assembly for receivingtherapeutic EMR from the laser assembly and facilitating the propagationof the therapeutic EMR from the laser assembly to and through the lighttransmission cable to the distal end of the light transmission cable,the EMR delivery fiber optic disposable comprising: a fiber opticdisposable, the fiber optic disposable having an elongate structure, aretracted mode, and a fiber-advanced mode and comprises a fiber optic, aproximal end for connection to the distal end of the light transmissioncable, a distal end for advancing into the lumen of the tubularstructure, the fiber optic is maintained in a sterile environment whenthe fiber optic disposable is in the retracted mode, when the fiberoptic is advanced into the lumen of the tubular structure the fiberoptic disposable is in the fiber-advanced mode, the fiber optic beingconducive to the axial propagation of the therapeutic EMR relative tothe tubular structure, the fiber optic further comprises at least oneradial emission portion disposed between the proximal end of the fiberoptic and a distal end of the fiber optic.
 16. The EMR delivery fiberoptic disposable of claim 15 wherein the EMR delivery system furthercomprises a fiber optic introducer for disposition intermediate of thefiber optic disposable and the tubular structure, the fiber opticintroducer comprising a main line, an entry port, an exit port, abranching line, and a side port.
 17. The EMR delivery fiber opticdisposable of claim 16 wherein the main line is tubular and has theentry port and the exit port disposed at opposite ends of the mainlineand the branching line communicates with the main line and has the sideport forming a Y-connector, the entry port is connected to the distalend of the fiber optic disposable, the exit port is connected to thetubular structure, the side port is connected to a second tubularstructure, the fiber optic passes through the entry port into the mainline and through the exit port into the tubular structure when the fiberoptic disposable is in the fiber-advanced mode, fluid flows through theexit port, the main line, the branching line, the side port, into andout of the second tubular structure.
 18. The EMR delivery fiber opticdisposable of claim 17 wherein the fiber optic has at least one radialemission portion disposed within the main line.
 19. The EMR deliveryfiber optic disposable of claim 17 wherein the fiber optic has at leastone radial emission portion disposed within the tubular structure. 20.The EMR delivery fiber optic disposable of claim 16 wherein the mainline is tubular and has the entry port and the exit port disposed atopposite ends of the mainline and the branching line communicates withthe main line and has the side port forming a Y-connector, the entryport is connected to the distal end of the fiber optic disposable, theexit port is connected to the tubular structure, the side port isconnected to a second tubular structure, the fiber optic passes throughthe entry port into the main line and through the branching line andside port into the second tubular structure when the fiber opticdisposable is in the fiber-advanced mode, fluid dialysate flows throughthe exit port, the main line, the branching line, the side port, intoand out of the second tubular structure.